Cleared Traditional

K982646 - AILEE SUTURES AND AILEE NEEDLES

K982646 is an FDA 510(k) clearance for AILEE SUTURES AND AILEE NEEDLES, manufactured by Myco Medical Supplies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K982646 · Myco Medical Supplies, Inc. · General & Plastic Surgery device
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Jun 1999
Decision
308d
Days
Class 2
Risk

K982646 is an FDA 510(k) clearance for the AILEE SUTURES AND AILEE NEEDLES. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on June 2, 1999 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Myco Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K982646

510(k) Number K982646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1998
Decision Date June 02, 1999
Days to Decision 308 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 115d · This submission: 308d
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 22
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K982646.
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
K000542 · Arc Medical Supplies (Beijing) Co, Ltd. · Apr 2000
LIGA-LOOP SUTURE APPLICATOR
K993695 · Hysterx, Inc. · Apr 2000
PLAIN/CHROMIC CATGUT
K994002 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
K991223 · Aesculap, Inc. · Apr 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