Cleared Traditional

K981128 - SOFSILK SUTURE

K981128 is the FDA 510(k) clearance for SOFSILK SUTURE by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code GAP) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K981128 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
42d
Days
Class 2
Risk

K981128 is an FDA 510(k) clearance for the SOFSILK SUTURE. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K981128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1998
Decision Date May 11, 1998
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 18
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K981128.
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184 · Cp Medical · Jun 2000
SILK SUTURE
K982853 · Davis & Geck, Inc. · Apr 1999
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089 · Aesculap, Inc. · Mar 1999
SOFSILK SUTURE
K980124 · United States Surgical, A Division of Tyco Healthc · Mar 1998
SOFSILK
K964581 · United States Surgical, A Division of Tyco Healthc · Jan 1997
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K930739 · Deknatel, Inc. · Jul 1994