Harvest Graft Delivery Syringe
FDA 510(k) K043261 · Harvest Technologies, Corp.
510(k) numberK043261
Submission
- Device name
- Harvest Graft Delivery Syringe
- Applicant
- Harvest Technologies, Corp.
Plymouth, MA, US - Received
- November 24, 2004
- Decision date
- March 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121005 | Adiprep Adipose Transfer SystemMUU · Traditional | 09/21/2012SE |
| K103340 | SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemJQC · Special | 12/06/2010SE |
| K052925 | SMARTPREP2 Centrifuge SystemJQC · Traditional | 01/04/2006SE |
| K020252 | Smartjet Grafting Liquid Applicator, Models Sk/S & LK/2FMF · Traditional | 04/05/2002SE |
| K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model Sk/S, Smartjet Bone Graft…LYC · Traditional | 07/03/2001SE |
| K000456 | Harvest Technologies Dual Liquid Applicator, Model Sk/S: Harvest Dual Liquid Applicator…FMF · Traditional | 06/01/2000SE |
| K991430 | Smartprep Centrifuge SystemJQC · Traditional | 05/28/1999SE |
| K983022 | Smartcell Processing SystemCAC · Traditional | 04/02/1999SE |
Questions and answers
When was Harvest Graft Delivery Syringe cleared by the FDA?
Harvest Graft Delivery Syringe (K043261) received a 510(k) decision of Substantially Equivalent on March 11, 2005, 107 days after the submission was received.
What is the product code of K043261?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.