Cleared Special

K091900 - ABSORBATACK 5MM SINGLE USE ABSORBABLE F...

K091900 is an FDA 510(k) clearance for ABSORBATACK 5MM SINGLE USE ABSORBABLE F..., manufactured by Covidien Lp, Formerly Registered AS United States. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 21-day FDA review.

K091900 · Covidien Lp, Formerly Registered AS United States · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
21d
Days
Class 2
Risk

K091900 is an FDA 510(k) clearance for the ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien Lp, Formerly Registered AS United States (North Haven, US). The FDA issued a Cleared decision on July 16, 2009 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Covidien Lp, Formerly Registered AS United States devices

FDA 510(k) Submission Details - K091900

510(k) Number K091900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2009
Decision Date July 16, 2009
Days to Decision 21 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 160
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K091900.
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
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
K091322 · Ethicon Endo-Surgery, Inc. · Jun 2009
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