Cleared Traditional

K122781 - RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD

K122781 is an FDA 510(k) clearance for RELIAMAX GASTROINTESTINAL ANASTOMOSIS A..., manufactured by Covidien, Formerly US Surgical A Divison of Tyco H. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K122781 · Covidien, Formerly US Surgical A Divison of Tyco H · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
147d
Days
Class 2
Risk

K122781 is an FDA 510(k) clearance for the RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien, Formerly US Surgical A Divison of Tyco H (North Haven, US). The FDA issued a Cleared decision on February 5, 2013 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Covidien, Formerly US Surgical A Divison of Tyco H devices

FDA 510(k) Submission Details - K122781

510(k) Number K122781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2012
Decision Date February 05, 2013
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
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 184
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K122781.
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K132493 · Covidien, LLC · Oct 2013
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
K131663 · Ethicon Endo-Surgery, LLC · Oct 2013
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
K130653 · Ethicon Endo-Surgery, LLC · Mar 2013
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
K123114 · Ethicon, Inc. · Feb 2013
PERMASORB DISPOSABLE FIXATION DEVICE
K123718 · C.R. Bard, Inc. · Jan 2013
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K123109 · Covidien · Oct 2012