Cleared Traditional

K043261 - HARVEST GRAFT DELIVERY SYRINGE

K043261 is an FDA 510(k) clearance for HARVEST GRAFT DELIVERY SYRINGE, manufactured by Harvest Technologies, Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K043261 · Harvest Technologies, Corp. · General Hospital
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Mar 2005
Decision
107d
Days
Class 2
Risk

K043261 is an FDA 510(k) clearance for the HARVEST GRAFT DELIVERY SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Harvest Technologies, Corp. (Plymouth, US). The FDA issued a Cleared decision on March 11, 2005 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Harvest Technologies, Corp. devices

FDA 510(k) Submission Details - K043261

510(k) Number K043261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date March 11, 2005
Days to Decision 107 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K043261.
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EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
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DUOPROSS SYRINGES
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PROCEDUR 10 SYRINGE DEVICE
K042486 · Avanca Medical Devices, Inc. · Jan 2005
TRUGRAFT BGS SYRINGE, MODEL 600-041
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