Cleared Special

K101444 - AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY

K101444 is an FDA 510(k) clearance for AUTOSUTURE ENDO GIA SINGLE USE TAN RELO..., manufactured by Surgical Devices, A Global Business Unit Tyco. 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.

K101444 · Surgical Devices, A Global Business Unit Tyco · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
21d
Days
Class 2
Risk

K101444 is an FDA 510(k) clearance for the AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Surgical Devices, A Global Business Unit Tyco (North Haven, US). The FDA issued a Cleared decision on June 14, 2010 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 Surgical Devices, A Global Business Unit Tyco devices

FDA 510(k) Submission Details - K101444

510(k) Number K101444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2010
Decision Date June 14, 2010
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 187
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K101444.
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ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
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K092483 · C.R. Bard, Inc. · Dec 2009
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K092577 · Ethicon Endo-Surgery, LLC · Sep 2009