Cleared Traditional

K082662 - V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

K082662 is an FDA 510(k) clearance for V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE, 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 Traditional 510(k) pathway after a 195-day FDA review.

K082662 · Surgical Devices, Tyco Healthcare Group LP · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
195d
Days
Class 2
Risk

K082662 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, Tyco Healthcare Group LP (North Haven, US). The FDA issued a Cleared decision on March 26, 2009 after a review of 195 days - an extended review 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Devices, Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K082662

510(k) Number K082662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date March 26, 2009
Days to Decision 195 days
Submission Type Traditional
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
80d slower than avg
Panel avg: 115d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K082662.
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
K100257 · Surgical Devices, A Division of Tyco Healthcare · May 2010
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K093408 · Surgical Devices, A Division of Tyco Healthcare · Nov 2009
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K091087 · Surgical Devices, Tyco Healthcare Group LP · Apr 2009
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
K080412 · Shanghai Pudong Jinhuan Medical Products Co., Ltd. · Sep 2008
MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
K081002 · Sutures India Pvt., Ltd. · Jun 2008
TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
K081003 · Sutures India Pvt., Ltd. · Jun 2008