IMC PISTON SYRINGES— 510(k) K102969

Clearance details

Applicant

International Medsurg Connection

Product code

Code FMF

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2010-10-06

Decision date

2010-12-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Schaumburg, IL, US

• K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
• K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray2026-08-25
• K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)2026-08-14
• K260208 — Ultra-Fine SAFETY Insulin Syringe2026-07-13
• K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18

• K110656 — IMC BLOOD COLLECTION NEEDLE2011-08-18
• K110882 — IMC INSULIN SYRINGE2011-08-18
• K102584 — IMC HYPODERMIC NEEDLE2011-01-14
• K100991 — IMC SURGICAL DRAPE2010-10-05
• K100846 — IMC SURGICAL FACE MASK2010-08-16

Death

15

Injury

2,263

Malfunction

29,722

Other

17

Total

32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0938-2023 — HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.Class II·Ongoing·Stradis Healthcare·20221215
• Z-0939-2023 — HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.Class II·Ongoing·Stradis Healthcare·20221215
• Z-2825-2017 — Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2826-2017 — Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2827-2017 — Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/caseClass II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2828-2017 — Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2829-2017 — Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2830-2017 — Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2831-2017 — Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2832-2017 — Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2833-2017 — Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2834-2017 — Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2835-201 — Piston Syringe and Hypodermic Needle, 3 CC L/L 23 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2836-201 — Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2837-201 — Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2838-201 — Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2839-2017 — Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2840-2017 — Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2841-2017 — Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623
• Z-2842-2017 — Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.Class II·Terminated·International Medsurg Connection, Inc.·20170623

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102969.