Cleared Special

K041201 - ULTRACLIP II MR

K041201 is an FDA 510(k) clearance for ULTRACLIP II MR, manufactured by Inrad. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 27-day FDA review.

K041201 · Inrad · General & Plastic Surgery device
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Jun 2004
Decision
27d
Days
Class 2
Risk

K041201 is an FDA 510(k) clearance for the ULTRACLIP II MR. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Inrad (Kentwood, US). The FDA issued a Cleared decision on June 3, 2004 after a review of 27 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 Inrad devices

FDA 510(k) Submission Details - K041201

510(k) Number K041201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2004
Decision Date June 03, 2004
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 K041201.
CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
K053631 · Ethicon Endo-Surgery, Inc. · Jan 2006
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K051301 · Ethicon Endo-Surgery, Inc. · Aug 2005
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
K051002 · Ethicon Endo-Surgery, Inc. · May 2005
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · Ethicon Endo-Surgery, Inc. · Feb 2004
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
K032973 · Vanguard Medical Concepts, Inc. · Dec 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
K032696 · United States Surgical, A Division of Tyco Healthc · Dec 2003