Cleared Traditional

POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (K961389) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961389 · R. K. Medical L. L. C. · General & Plastic Surgery device
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Jun 1996
Decision
69d
Days
Class 2
Risk

K961389 is an FDA 510(k) clearance for the POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by R. K. Medical L. L. C. (Mahwah, US). The FDA issued a Cleared decision on June 18, 1996 after a review of 69 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 R. K. Medical L. L. C. devices

Submission Details

510(k) Number K961389 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 10, 1996
Decision Date June 18, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
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 20
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K961389.
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc · Jun 2005
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc. · Jul 2000
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · Aesculap, Inc. · May 1998
VIEWPOINT
K961168 · Philips Medical Systems (Cleveland), Inc. · May 1996
USSC POLYPROPLENE SUTURE
K954808 · United States Surgical, A Division of Tyco Healthc · Feb 1996
SYNTHETIC ABSORBABLE SUTURE, UNDYED
K920437 · Ethicon, Inc. · Jul 1992