FDA 510(k)

PTFE SURGICAL SUTURE

K-Number: K180630 · 2018-04-06

Decision Date2018-04-06

Product CodeNBY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PTFE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Spa. It received FDA 510(k) clearance on 2018-04-06 under 510(k) number K180630. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTFE SURGICAL SUTURE?

PTFE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Omnia Spa. The 510(k) number is K180630.

When did PTFE SURGICAL SUTURE receive FDA 510(k) clearance?

PTFE SURGICAL SUTURE received FDA 510(k) clearance on 2018-04-06, under 510(k) number K180630.

Who is the listed applicant for PTFE SURGICAL SUTURE?

The FDA 510(k) record lists Omnia Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTFE SURGICAL SUTURE?

The FDA product code for PTFE SURGICAL SUTURE is NBY.

Related Devices (Code: NBY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231277TissueStatDurastat, LLC K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures K180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami Surgical K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K173922C-PTFETM Surgical SutureCp Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.