Cleared Special

PTFE SURGICAL SUTURE (K180630) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180630 · Omnia Spa · General & Plastic Surgery device
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Apr 2018
Decision
28d
Days
Class 2
Risk

K180630 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 (Fidenza, IT). The FDA issued a Cleared decision on April 6, 2018 after a review of 28 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omnia Spa devices

Submission Details

510(k) Number K180630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date April 06, 2018
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

THEMA S.r.l.
Marisa Testa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

All 7
Devices cleared under the same product code (NBY) and FDA review panel - the closest regulatory comparables to K180630.
Biotex
K180992 · Purgo Biologics, Inc. · Jul 2019
StitchKit
K191317 · Origami Surgical · Jul 2019
DemeTECH PTFE Nonabsorbable Surgical Suture
K181578 · Demetech Corporation · Oct 2018
C-PTFETM Surgical Suture
K173922 · Cp Medical, Inc. · Mar 2018
Gazelle PTFE and Suture Delivery Device
K173335 · Dura Tap, LLC · Feb 2018