FDA 510(k)

LOOK PTFE Suture

K-Number: K160744 · 2016-07-13

ApplicantSurgical Specialties Corporation

Decision Date2016-07-13

Product CodeNBY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LOOK PTFE Suture is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corporation. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K160744. 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 LOOK PTFE Suture?

LOOK PTFE Suture is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Surgical Specialties Corporation. The 510(k) number is K160744.

When did LOOK PTFE Suture receive FDA 510(k) clearance?

LOOK PTFE Suture received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160744.

Who is the listed applicant for LOOK PTFE Suture?

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

What is the FDA product code for LOOK PTFE Suture?

The FDA product code for LOOK PTFE 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 K180630PTFE SURGICAL SUTUREOmnia Spa

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.