Cleared Traditional

K993997 - POLYPROPYLENE

K993997 is an FDA 510(k) clearance for POLYPROPYLENE, manufactured by Trading Consultants and Distributors Intl., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K993997 · 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
72d
Days
Class 2
Risk

K993997 is an FDA 510(k) clearance for the POLYPROPYLENE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Trading Consultants and Distributors Intl., Inc. (Chicago, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 - K993997

510(k) Number K993997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date February 04, 2000
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 45
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K993997.
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
K002435 · Axya Medical, Inc. · Aug 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc. · Jul 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185 · Cp Medical · Jun 2000
MODIFICATION TO BONE ANCHOR AND KIT (BAK)
K994313 · Axya Medical, Inc. · Jan 2000
AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)
K992405 · Axya Medical, Inc. · Sep 1999
SUTURE WELDING SYSTEM AND KIT (SWK)
K983108 · Axya Medical, Inc. · Nov 1998