Cleared Traditional

K944110 - VICRYL RAPIDE SUTURE

K944110 is the FDA 510(k) clearance for VICRYL RAPIDE SUTURE by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAM) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K944110 · Ethicon, Inc. · General & Plastic Surgery device
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Jan 1995
Decision
148d
Days
Class 2
Risk

K944110 is an FDA 510(k) clearance for the VICRYL RAPIDE SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 18, 1995 after a review of 148 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 Ethicon, Inc. devices

Submission Details

510(k) Number K944110 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 23, 1994
Decision Date January 18, 1995
Days to Decision 148 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 115d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K944110.
USSC POLYSORB SUTURE
K951520 · United States Surgical, A Division of Tyco Healthc · Aug 1995
VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT
K946271 · Ethicon, Inc. · Jun 1995
DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE
K951352 · Davis & Geck, Inc. · Jun 1995
DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID
K930588 · Davis & Geck, Inc. · Jan 1994
ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE
K930772 · Ethicon, Inc. · Jan 1994
SUTURES
K930360 · Ethicon, Inc. · Dec 1993