Cleared Special

K091087 - MODIFICATION TO V-LOC 180 ABSORBABLE WO...

K091087 is an FDA 510(k) clearance for MODIFICATION TO V-LOC 180 ABSORBABLE WO..., manufactured by Surgical Devices, Tyco Healthcare Group LP. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Special 510(k) pathway after a 7-day FDA review.

K091087 · Surgical Devices, Tyco Healthcare Group LP · General & Plastic Surgery device
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Apr 2009
Decision
7d
Days
Class 2
Risk

K091087 is an FDA 510(k) clearance for the MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Surgical Devices, Tyco Healthcare Group LP (North Haven, US). The FDA issued a Cleared decision on April 22, 2009 after a review of 7 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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, Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K091087

510(k) Number K091087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2009
Decision Date April 22, 2009
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 87
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K091087.
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MONOSWIFT
K072229 · Cp Medical · Oct 2007
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
K072028 · Surgical Specialties Corp · Aug 2007