HARVEST GRAFT DELIVERY SYRINGE— 510(k) K043261
Substantially EquivalentHarvest Technologies, Corp.
FDA 510(k) clearance K043261 for HARVEST GRAFT DELIVERY SYRINGE, Substantially Equivalent on 2005-03-11. Applicant: Harvest Technologies, Corp.. Device class: 2.
Clearance details
- Applicant
- Harvest Technologies, Corp.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MA, US
Recent devices under product code FMF
view allMore clearances from Harvest Technologies, Corp.
view all- K121005 — ADIPREP ADIPOSE TRANSFER SYSTEM
- K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
- K052925 — SMARTPREP2 CENTRIFUGE SYSTEM
- K020252 — SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2
- K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K043261
K-number listed on FDA's recall record- Z-0075-2018 — HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
- Z-0022-2014 — Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043261.
Data sourced from openFDA. This site is unofficial and independent of the FDA.