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FDA 510(k)

TEPHAFLEX ABSORBABLE SUTURE

K-Number: K082178 · 2008-10-30

ApplicantTepha, Inc.
Decision Date2008-10-30
Product CodeNWJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TEPHAFLEX ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2008-10-30 under 510(k) number K082178. The device is classified under product code NWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEPHAFLEX ABSORBABLE SUTURE?

TEPHAFLEX ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2008-10-30. The listed applicant is Tepha, Inc.. The 510(k) number is K082178.

When did TEPHAFLEX ABSORBABLE SUTURE receive FDA 510(k) clearance?

TEPHAFLEX ABSORBABLE SUTURE received FDA 510(k) clearance on 2008-10-30, under 510(k) number K082178.

Who is the listed applicant for TEPHAFLEX ABSORBABLE SUTURE?

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

What is the FDA product code for TEPHAFLEX ABSORBABLE SUTURE?

The FDA product code for TEPHAFLEX ABSORBABLE SUTURE is NWJ.

Related Clinical Trials

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Other records listing Tepha, Inc. as applicant

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.

K233999GalaFLEX LITE ScaffoldK202425SurgiLattice scaffoldK211307GalaSTITCH Absorbable Monofilament SutureK162922GalaFORM 3DK161092GalaSHAPE 3DK132348TEPHAFLEX BRAIDED SUTURE

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Related Devices (Code: NWJ)

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.

K211307GalaSTITCH Absorbable Monofilament SutureTepha, Inc.K132348TEPHAFLEX BRAIDED SUTURETepha, Inc.K130422PHANTOM FIBER BIOFIBER SUTURETornier, Inc.K122487BIOFIBER SYTURETornier, Inc.K100876AESCULAP MONOMAX ABSORBABLE SUTUREAesculap, Inc.K081099TEPHAFLEX ABSORBABLE SUTURETepha, Inc.

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.

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