Cleared Traditional

K961931 - PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP

K961931 is an FDA 510(k) clearance for PLAIN GUT & CHRONIC GUT ABSORBABLE SURG..., manufactured by R. K. Medical L. L. C.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K961931 · R. K. Medical L. L. C. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
73d
Days
Class 2
Risk

K961931 is an FDA 510(k) clearance for the PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by R. K. Medical L. L. C. (Mahwah, US). The FDA issued a Cleared decision on July 29, 1996 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4830 - 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 - K961931

510(k) Number K961931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date July 29, 1996
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAL Device Classification - Class 2, Special Controls

Product Code GAL Suture, Absorbable, Natural
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
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 - GAL Suture, Absorbable, Natural

All 17
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K961931.
PLAIN/CHROMIC CATGUT
K994002 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
AILEE SUTURES AND AILEE NEEDLES
K982646 · Myco Medical Supplies, Inc. · Jun 1999
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
K991223 · Aesculap, Inc. · Apr 1999
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
K930738 · Deknatel, Inc. · Jul 1994
SURGICAL SUTURE PACKAGE INSERTS
K930416 · United States Surgical, A Division of Tyco Healthc · Apr 1994
REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES
K926586 · Look, Inc. · Dec 1993