Cleared Traditional

K042141 - POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE

K042141 is an FDA 510(k) clearance for POLYGLYTONE 6211 SYNTHETIC ABSORBABLE S..., manufactured by Teleflex Medical. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K042141 · Teleflex Medical · General & Plastic Surgery device
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Sep 2004
Decision
50d
Days
Class 2
Risk

K042141 is an FDA 510(k) clearance for the POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Teleflex Medical (Fall River, US). The FDA issued a Cleared decision on September 28, 2004 after a review of 50 days - a notably fast clearance cycle.

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: 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 Teleflex Medical devices

FDA 510(k) Submission Details - K042141

510(k) Number K042141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date September 28, 2004
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 122
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K042141.
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
K043539 · Demetech Corp. · Apr 2005
ENDOTINE RIBBON
K050611 · Coapt Systems, Inc. · Apr 2005
UNICRYL
K042288 · United Medical Industries Co. , Ltd. · Dec 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K042233 · Depuy Mitek, A Johnson & Johnson Company · Sep 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K041806 · Depuy Mitek, A Johnson & Johnson Company · Aug 2004
MONODERM
K040477 · Surgical Specialties Corp · May 2004