Cleared Traditional

K960328 - SILK NONABSORBABLE SURGICAL SUTURES USP

K960328 is an FDA 510(k) clearance for SILK NONABSORBABLE SURGICAL SUTURES USP, manufactured by R. K. Medical L. L. C.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K960328 · R. K. Medical L. L. C. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
40d
Days
Class 2
Risk

K960328 is an FDA 510(k) clearance for the SILK NONABSORBABLE SURGICAL SUTURES USP. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by R. K. Medical L. L. C. (Mahwah, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 40 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - 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

FDA 510(k) Submission Details - K960328

510(k) Number K960328 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 24, 1996
Decision Date March 04, 1996
Days to Decision 40 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 25
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K960328.
SOFSILK SUTURE
K981128 · United States Surgical, A Division of Tyco Healthc · May 1998
SOFSILK SUTURE
K980124 · United States Surgical, A Division of Tyco Healthc · Mar 1998
SOFSILK
K964581 · United States Surgical, A Division of Tyco Healthc · Jan 1997
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K930739 · Deknatel, Inc. · Jul 1994
VISITEC PRECISE-POINT
K942234 · Visitec Co. · Jul 1994
NONABSORBABLE SILK SURGICAL SUTURE
K904478 · United States Surgical, A Division of Tyco Healthc · Nov 1990