Cleared Traditional

K132464 - PTFE SURGICAL SUTURE

K132464 is an FDA 510(k) clearance for PTFE SURGICAL SUTURE, manufactured by Omnia Spa. The device is a Class 2 General & Plastic Surgery device with product code NBY cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K132464 · Omnia Spa · General & Plastic Surgery device
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Feb 2014
Decision
189d
Days
Class 2
Risk

K132464 is an FDA 510(k) clearance for the PTFE SURGICAL SUTURE. Classified as Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY), Class II - Special Controls.

Submitted by Omnia Spa (Imola, IT). The FDA issued a Cleared decision on February 12, 2014 after a review of 189 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5035 - 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 Omnia Spa devices

FDA 510(k) Submission Details - K132464

510(k) Number K132464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2013
Decision Date February 12, 2014
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBY Device Classification - Class 2, Special Controls

Product Code NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5035
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 - NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

All 16
Devices cleared under the same product code (NBY) and FDA review panel - the closest regulatory comparables to K132464.
LS-5 ePTFE Suture
K163639 · Lsi Solutions · Jun 2017
LOOK PTFE Suture
K160744 · Surgical Specialties Corporation · Jul 2016
MONOTEX
K140415 · Riverpoint Medical · Mar 2014
STITCHKIT
K123811 · Origami Surgical, LLC · Sep 2013
CYTOPLAST PTFE SUTURE
K072076 · Osteogenics Biomedical, Inc. · Oct 2007
CYTOPLAST SUTURE
K003028 · Osteogenics Biomedical, Inc. · Nov 2000