Cleared Traditional

K994001 - POLYGLYCOLIC ACID

K994001 is an FDA 510(k) clearance for POLYGLYCOLIC ACID, manufactured by Trading Consultants and Distributors Intl., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K994001 · Trading Consultants and Distributors Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
77d
Days
Class 2
Risk

K994001 is an FDA 510(k) clearance for the POLYGLYCOLIC ACID. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Trading Consultants and Distributors Intl., Inc. (Chicago, US). The FDA issued a Cleared decision on February 9, 2000 after a review of 77 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 Trading Consultants and Distributors Intl., Inc. devices

FDA 510(k) Submission Details - K994001

510(k) Number K994001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date February 09, 2000
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 96
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K994001.
BIOKNOTLESS ANCHOR
K002639 · Mitek Products · May 2001
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
K002190 · Cp Medical · Aug 2000
MONOFILAMENT BIOSYN SUTURE
K000037 · United States Surgical, A Division of Tyco Healthc · Mar 2000
BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
K992088 · Genzyme Surgical Product (Genzyme Biosurgery) · Sep 1999
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
K991191 · Genzyme Surgical Product (Genzyme Biosurgery) · Jun 1999
SURGISORB
K984374 · Samyang Corp. · Jun 1999