Cleared Traditional

K993695 - LIGA-LOOP SUTURE APPLICATOR

K993695 is an FDA 510(k) clearance for LIGA-LOOP SUTURE APPLICATOR, manufactured by Hysterx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K993695 · Hysterx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
163d
Days
Class 2
Risk

K993695 is an FDA 510(k) clearance for the LIGA-LOOP SUTURE APPLICATOR. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Hysterx, Inc. (Irvine, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Hysterx, Inc. devices

FDA 510(k) Submission Details - K993695

510(k) Number K993695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1999
Decision Date April 13, 2000
Days to Decision 163 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
48d slower than avg
Panel avg: 115d · This submission: 163d
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 15
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K993695.
Surgical Gut Suture
K142656 · Covidien · Jan 2015
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
K042897 · Ethicon Endo-Surgery, Inc. · Nov 2004
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
K001299 · Cp Medical · Jun 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
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
K991223 · Aesculap, Inc. · Apr 1999