Cleared Traditional

SURGISILK (K943627) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943627 · Sutures , Ltd. · General & Plastic Surgery device
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Dec 1994
Decision
132d
Days
Class 2
Risk

K943627 is an FDA 510(k) clearance for the SURGISILK. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Sutures , Ltd. (Ruabon, Wrexham, GB). The FDA issued a Cleared decision on December 5, 1994 after a review of 132 days - within the typical 510(k) review window.

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: 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 Sutures , Ltd. devices

Submission Details

510(k) Number K943627 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 26, 1994
Decision Date December 05, 1994
Days to Decision 132 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
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 11
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K943627.
SOFSILK SUTURE
K981128 · United States Surgical, A Division of Tyco Healthc · May 1998
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
NONABSORBABLE SILK SURGICAL SUTURE
K904478 · United States Surgical, A Division of Tyco Healthc · Nov 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
K904891 · United States Surgical, A Division of Tyco Healthc · Nov 1990