Disposable Sterile Syringe, with/without needle +1 more— 510(k) K212033

Clearance details

Device name as filed

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

Applicant

Shandong Zhushi Pharmaceutical Group Co., Ltd.

Product code

Code FMF

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2021-06-29

Decision date

2022-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Heze, CN

• 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

• K232475 — Disposable infusion set with needle2024-05-10
• K210510 — Disposable Surgical Gown2021-08-12
• K210643 — Disposable Surgical Face Mask2021-08-04
• K210409 — Disposable Surgical Face Mask2021-07-28
• K203454 — Infrared Thermometer2021-04-29

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 →