Cleared Traditional

K943220 - SUTULENE

K943220 is an FDA 510(k) clearance for SUTULENE, manufactured by Sutures , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K943220 · Sutures , Ltd. · General & Plastic Surgery device
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Dec 1994
Decision
153d
Days
Class 2
Risk

K943220 is an FDA 510(k) clearance for the SUTULENE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 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 153 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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

FDA 510(k) Submission Details - K943220

510(k) Number K943220 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 05, 1994
Decision Date December 05, 1994
Days to Decision 153 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
38d slower than avg
Panel avg: 115d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 121
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K943220.
ACUFEX DOUBLE ARMED SUTURE NEEDLE
K970416 · Smith & Nephew Endoscopy, Inc. · Apr 1997
USSC NONABSORBABLE SUTURES
K955747 · United States Surgical, A Division of Tyco Healthc · Feb 1996
ACUFEX ENDOBUTTON TAPE
K952535 · Acufex Microsurgical, Inc. · Feb 1996
POLYVIOLENE SURGICL SUTURE
K943949 · Look, Inc. · Nov 1994
POLYVIOLENE SUTURE-REVISED LABELING
K926167 · Look, Inc. · Dec 1993
SILK SUTURES
K930590 · Davis & Geck, Inc. · Dec 1993