Cleared Traditional

K093524 - PIVIT A/B ST AND PIVIT A/B ST-R

K093524 is an FDA 510(k) clearance for PIVIT A/B ST AND PIVIT A/B ST-R, manufactured by Tyrx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K093524 · Tyrx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
130d
Days
Class 2
Risk

K093524 is an FDA 510(k) clearance for the PIVIT A/B ST AND PIVIT A/B ST-R. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tyrx, Inc. (Monmouth Junction, US). The FDA issued a Cleared decision on March 26, 2010 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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.

FDA 510(k) Submission Details - K093524

510(k) Number K093524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2009
Decision Date March 26, 2010
Days to Decision 130 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
15d slower than avg
Panel avg: 115d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTL Mesh, Surgical, Polymeric

All 334
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K093524.
TORNIER SURGICAL MESH
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VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
K093932 · Ethicon GmbH · Apr 2010
REFINE SUPPORT SYSTEM, MODEL 100.0100
K092538 · Alure Medical, Inc. · Mar 2010
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp. · Jan 2010
TIGR SURGICAL MESH , MODEL WK-6
K092224 · Novus Scientific Pte, Ltd. · Jan 2010