Cleared Traditional

K100257 - VLOC9ABSORBABLE WOUND CLOSURE DEVICE

K100257 is an FDA 510(k) clearance for VLOC9ABSORBABLE 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 Traditional 510(k) pathway after a 102-day FDA review.

K100257 · Surgical Devices, A Division of Tyco Healthcare · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
102d
Days
Class 2
Risk

K100257 is an FDA 510(k) clearance for the VLOC9ABSORBABLE 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 May 10, 2010 after a review of 102 days - within the typical 510(k) review window.

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, A Division of Tyco Healthcare devices

FDA 510(k) Submission Details - K100257

510(k) Number K100257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2010
Decision Date May 10, 2010
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
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 87
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K100257.
MONODERM SURGICAL SUTURE
K140227 · Surgical Specialties Corp · Feb 2014
AESCULAP NOVOSYN ABSORBABLE SUTURE
K122734 · Aesculap, Inc. · Dec 2012
VILET VILET QUICK
K120556 · Riverpoint Medical · May 2012
HEPATOSTAT SET
K073493 · Vygon Corp. · May 2008
MONOSWIFT
K072229 · Cp Medical · Oct 2007
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
K072028 · Surgical Specialties Corp · Aug 2007