Cleared Traditional

LEG URINAL (K913155) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913155 · Ezmt Valve Co., Inc. · General & Plastic Surgery device
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Sep 1991
Decision
61d
Days
Class 2
Risk

K913155 is an FDA 510(k) clearance for the LEG URINAL. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Ezmt Valve Co., Inc. (Salinas, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - 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 Ezmt Valve Co., Inc. devices

Submission Details

510(k) Number K913155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1991
Decision Date September 16, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
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 - GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

All 10
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K913155.
STEELEX STERNUM SET
K023411 · Aesculap, Inc. · Dec 2002
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
K946173 · Ethicon, Inc. · Jan 1995
ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE
K931271 · Ethicon, Inc. · Jan 1994
STAINLESS 22-13-5 SUTURE WIRE
K873645 · Zimmer, Inc. · Nov 1987