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
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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.

View all Covidien devices

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 222
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K102291.
PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER
K103470 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Jan 2011
ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY
K103263 · Covidien, Formerly US Surgical A Divison of Tyco H · Nov 2010
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
K102632 · Ethicon Endo-Surgery, Inc. · Oct 2010
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
K093845 · Ethicon, Inc. · Apr 2010
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · C.R. Bard, Inc. · Dec 2009
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
K092577 · Ethicon Endo-Surgery, LLC · Sep 2009