Cleared Traditional

K102291 - COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

K102291 is an FDA 510(k) clearance for COVIDIEN ENDO GIA RADIAL RELOAD WITH TR..., manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K102291 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
34d
Days
Class 2
Risk

K102291 is an FDA 510(k) clearance for the COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 34 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.

FDA 510(k) Submission Details - K102291

510(k) Number K102291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2010
Decision Date September 15, 2010
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 281
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K102291.
TIGERPAW SYSTEM
K101961 · Laax, Inc. · Oct 2010
IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
K102325 · Covidien, LLC, Formerly Registered AS Tyco Healthca · Oct 2010
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
K102632 · Ethicon Endo-Surgery, Inc. · Oct 2010
FRANKENMAN SURGICAL STAPLERS
K101378 · Suzhou Frankenman Medical Equipment Co., Ltd. · Jun 2010
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
K101444 · Surgical Devices, A Global Business Unit Tyco · Jun 2010
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5
K100723 · Changzhou Kangdi Medical Stapler Co., Ltd. · Apr 2010
K102291 · COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
Download PDF FDA Summary Covidien