Cleared Traditional

K990951 - MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE

K990951 is an FDA 510(k) clearance for MAXON** STERILE, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K990951 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
10d
Days
Class 2
Risk

K990951 is an FDA 510(k) clearance for the MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 1, 1999 after a review of 10 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K990951

510(k) Number K990951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date April 01, 1999
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
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 138
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K990951.
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
K991191 · Genzyme Surgical Product (Genzyme Biosurgery) · Jun 1999
SURGISORB
K984374 · Samyang Corp. · Jun 1999
SURGISORB
K990432 · Sutures , Ltd. · May 1999
POLYSORB SUTURE
K981935 · United States Surgical, A Division of Tyco Healthc · Jun 1998
DEXON RAPID (DEXON R)
K980610 · Davis & Geck, Inc. · May 1998
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
K980704 · Aesculap, Inc. · May 1998