Cleared Traditional

K043172 - TRUGRAFT BGS SYRINGE, MODEL 600-041

K043172 is an FDA 510(k) clearance for TRUGRAFT BGS SYRINGE, manufactured by Osteobiologics, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K043172 · Osteobiologics, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
52d
Days
Class 2
Risk

K043172 is an FDA 510(k) clearance for the TRUGRAFT BGS SYRINGE, MODEL 600-041. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Osteobiologics, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K043172

510(k) Number K043172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2004
Decision Date January 07, 2005
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 688
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K043172.
HARVEST GRAFT DELIVERY SYRINGE
K043261 · Harvest Technologies, Corp. · Mar 2005
DUOPROSS SYRINGES
K042500 · Duopross Meditech Corporation · Feb 2005
PROCEDUR 10 SYRINGE DEVICE
K042486 · Avanca Medical Devices, Inc. · Jan 2005
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
K042588 · Confluent Surgical,Inc · Dec 2004
DRAGON HEART PISTON SYRINGE
K042547 · Dragon Heart Medical Devices Co., Ltd. · Dec 2004
SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
K042314 · Biogen · Nov 2004
K043172 · TRUGRAFT BGS SYRINGE, MODEL 600-041
Download PDF FDA Summary Osteobiologics, Inc.