Cleared Traditional

K980703 - PREMILENE NONABSORBABLE POLYPROPYLENE S...

K980703 is the FDA 510(k) clearance for PREMILENE NONABSORBABLE POLYPROPYLENE S... by Aesculap, Inc.. It is a Class 2 General & Plastic Surgery device (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

Submission Details

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.

Device Classification

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 25
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K980703.
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc · Jun 2005
AMS SLING FIXATION SYSTEM
K010990 · American Medical Systems, Inc. · Jun 2001
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc. · Jul 2000
VIEWPOINT
K961168 · Philips Medical Systems (Cleveland), Inc. · May 1996
USSC POLYPROPLENE SUTURE
K954808 · United States Surgical, A Division of Tyco Healthc · Feb 1996
SURGILENE(R) SUTURES
K945701 · Davis & Geck, Inc. · Jan 1995