Cleared Traditional

K983108 - SUTURE WELDING SYSTEM AND KIT (SWK)

K983108 is an FDA 510(k) clearance for SUTURE WELDING SYSTEM AND KIT (SWK), manufactured by Axya Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K983108 · Axya Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
84d
Days
Class 2
Risk

K983108 is an FDA 510(k) clearance for the SUTURE WELDING SYSTEM AND KIT (SWK). Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Axya Medical, Inc. (Beverly, US). The FDA issued a Cleared decision on November 27, 1998 after a review of 84 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 Axya Medical, Inc. devices

FDA 510(k) Submission Details - K983108

510(k) Number K983108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1998
Decision Date November 27, 1998
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 43
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K983108.
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
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · Aesculap, Inc. · May 1998
VIEWPOINT
K961168 · Philips Medical Systems (Cleveland), Inc. · May 1996
CPR HEART PACK
K960209 · Custom Pack Reliability · Apr 1996