Cleared Traditional

K080898 - AUTO SUTURE ENDO GIA STAPLERS WITH ENDO...

K080898 is an FDA 510(k) clearance for AUTO SUTURE ENDO GIA STAPLERS WITH ENDO..., manufactured by Tyco Healthcare Group LP. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K080898 · Tyco Healthcare Group LP · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
35d
Days
Class 2
Risk

K080898 is an FDA 510(k) clearance for the AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STA.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Tyco Healthcare Group LP (North Haven, US). The FDA issued a Cleared decision on May 5, 2008 after a review of 35 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 Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K080898

510(k) Number K080898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date May 05, 2008
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 163
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K080898.
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
K082396 · C.R. Bard, Inc. · Jan 2009
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
K081146 · Ethicon Endo-Surgery, LLC · Jun 2008
ECHELON GRAY CARTRIDGE, MODEL ERC45M
K080839 · Ethicon Endo-Surgery, LLC · May 2008
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc · Sep 2007
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
K070887 · Ethicon Endo-Surgery, LLC · May 2007
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
K062869 · Ethicon Endo-Surgery, LLC · Feb 2007