Cleared Traditional

K991223 - ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC

K991223 is an FDA 510(k) clearance for ABSORBABLE SURGICAL GUT SUTURE, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K991223 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
18d
Days
Class 2
Risk

K991223 is an FDA 510(k) clearance for the ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURG.... Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on April 30, 1999 after a review of 18 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K991223

510(k) Number K991223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date April 30, 1999
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 K991223.
LIGA-LOOP SUTURE APPLICATOR
K993695 · Hysterx, Inc. · Apr 2000
PLAIN/CHROMIC CATGUT
K994002 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
AILEE SUTURES AND AILEE NEEDLES
K982646 · Myco Medical Supplies, Inc. · Jun 1999
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
K961931 · R. K. Medical L. L. C. · Jul 1996
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