FDA 510(k)

C-PTFETM Surgical Suture

K-Number: K173922 · 2018-03-26

Decision Date2018-03-26

Product CodeNBY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

C-PTFETM Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical, Inc.. It received FDA 510(k) clearance on 2018-03-26 under 510(k) number K173922. 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 C-PTFETM Surgical Suture?

C-PTFETM Surgical Suture is a medical device that received FDA 510(k) clearance on 2018-03-26. The listed applicant is Cp Medical, Inc.. The 510(k) number is K173922.

When did C-PTFETM Surgical Suture receive FDA 510(k) clearance?

C-PTFETM Surgical Suture received FDA 510(k) clearance on 2018-03-26, under 510(k) number K173922.

Who is the listed applicant for C-PTFETM Surgical Suture?

The FDA 510(k) record lists Cp Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-PTFETM Surgical Suture?

The FDA product code for C-PTFETM 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 K180630PTFE SURGICAL SUTUREOmnia Spa

Official Source

View on FDA Database →

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