Cleared Traditional

K942606 - SURGICAL STAPLE

K942606 is an FDA 510(k) clearance for SURGICAL STAPLE, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K942606 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
84d
Days
Class 2
Risk

K942606 is an FDA 510(k) clearance for the SURGICAL STAPLE. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on August 24, 1994 after a review of 84 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K942606

510(k) Number K942606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1994
Decision Date August 24, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
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 255
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K942606.
MICROMARK CLIP
K970817 · Biopsys Medical, Inc. · Sep 1997
SURGICAL STAPLE MARKER DEVICE (MODIFY)
K963015 · Biopsys Medical, Inc. · Oct 1996
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · United States Surgical, A Division of Tyco Healthc · Oct 1995
STRYKER STAPLER SYSTEM
K931103 · Stryker Endoscopy · Oct 1993
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
K920752 · Ethicon, Inc. · Aug 1992
HEM-O-LOK -- MODIFICATION
K922186 · Linvatec Corp. · Aug 1992