Cleared Traditional

K040109 - HEMORRHAGE OCCLUDER PIN

K040109 is an FDA 510(k) clearance for HEMORRHAGE OCCLUDER PIN, manufactured by Tools For Surgery, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K040109 · Tools For Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
65d
Days
Class 2
Risk

K040109 is an FDA 510(k) clearance for the HEMORRHAGE OCCLUDER PIN. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Tools For Surgery, LLC (Stony Brook, US). The FDA issued a Cleared decision on March 25, 2004 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery 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.

View all Tools For Surgery, LLC devices

FDA 510(k) Submission Details - K040109

510(k) Number K040109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date March 25, 2004
Days to Decision 65 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 162
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K040109.
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
K051848 · Davol Inc., Sub. C. R. Bard, Inc. · Aug 2005
SALUTE FIXATION SYSTEM
K050610 · Davol Inc., Sub. C. R. Bard, Inc. · May 2005
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
K051002 · Ethicon Endo-Surgery, Inc. · May 2005
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · Ethicon Endo-Surgery, Inc. · Feb 2004
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
K032973 · Vanguard Medical Concepts, Inc. · Dec 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
K032696 · United States Surgical, A Division of Tyco Healthc · Dec 2003