Cleared Traditional

K980703 - PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

K980703 is an FDA 510(k) clearance for PREMILENE NONABSORBABLE POLYPROPYLENE S..., manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K980703 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
70d
Days
Class 2
Risk

K980703 is an FDA 510(k) clearance for the PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on May 4, 1998 after a review of 70 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K980703

510(k) Number K980703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1998
Decision Date May 04, 1998
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 62
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K980703.
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
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K961389 · R. K. Medical L. L. C. · Jun 1996
VIEWPOINT
K961168 · Philips Medical Systems (Cleveland), Inc. · May 1996
CPR HEART PACK
K960209 · Custom Pack Reliability · Apr 1996