Cleared Special

K093408 - V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

K093408 is an FDA 510(k) clearance for V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE, manufactured by Surgical Devices, A Division of Tyco Healthcare. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Special 510(k) pathway after a 10-day FDA review.

K093408 · Surgical Devices, A Division of Tyco Healthcare · General & Plastic Surgery device
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Nov 2009
Decision
10d
Days
Class 2
Risk

K093408 is an FDA 510(k) clearance for the 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, A Division of Tyco Healthcare (North Haven, US). The FDA issued a Cleared decision on November 12, 2009 after a review of 10 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, A Division of Tyco Healthcare devices

FDA 510(k) Submission Details - K093408

510(k) Number K093408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2009
Decision Date November 12, 2009
Days to Decision 10 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 115d · This submission: 10d
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 145
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K093408.
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
K111442 · Covidien, Formerly US Surgical A Divison of Tyco H · Jun 2011
SUTRAZORB
K102592 · Visionary Medical Supplies, Inc. · Feb 2011
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
K100257 · Surgical Devices, A Division of Tyco Healthcare · May 2010
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K091087 · Surgical Devices, Tyco Healthcare Group LP · Apr 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K082662 · Surgical Devices, Tyco Healthcare Group LP · Mar 2009
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
K080412 · Shanghai Pudong Jinhuan Medical Products Co., Ltd. · Sep 2008