Cleared Traditional

K913185 - STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT

K913185 is an FDA 510(k) clearance for STERILE STAINLESS STEEL MONOFIL NONABSO..., manufactured by Internacional Farmaceutica, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K913185 · Internacional Farmaceutica, S.A. DE C.V. · General & Plastic Surgery device
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Dec 1991
Decision
139d
Days
Class 2
Risk

K913185 is an FDA 510(k) clearance for the STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Internacional Farmaceutica, S.A. DE C.V. (Great Neck, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 139 days - within the typical 510(k) review window.

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: 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 Internacional Farmaceutica, S.A. DE C.V. devices

FDA 510(k) Submission Details - K913185

510(k) Number K913185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1991
Decision Date December 04, 1991
Days to Decision 139 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAQ Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K913185.
SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL
K930740 · Deknatel, Inc. · Jul 1994
ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE
K931271 · Ethicon, Inc. · Jan 1994
LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE
K933686 · Look, Inc. · Dec 1993
PTI STERNAL CLOSURE WIRE SUTURE
K910067 · Pioneering Technologies, Inc. · May 1991
STAINLESS 22-13-5 SUTURE WIRE
K873645 · Zimmer, Inc. · Nov 1987