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FDA 510(k)

TEPHAFLEX MESH

K-Number: K111946 · 2011-09-26

ApplicantTepha, Inc.
Decision Date2011-09-26
Product CodeOOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TEPHAFLEX MESH is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2011-09-26 under 510(k) number K111946. The device is classified under product code OOD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEPHAFLEX MESH?

TEPHAFLEX MESH is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Tepha, Inc.. The 510(k) number is K111946.

When did TEPHAFLEX MESH receive FDA 510(k) clearance?

TEPHAFLEX MESH received FDA 510(k) clearance on 2011-09-26, under 510(k) number K111946.

Who is the listed applicant for TEPHAFLEX MESH?

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 MESH?

The FDA product code for TEPHAFLEX MESH is OOD.

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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: OOD)

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 ScaffoldTepha, Inc.K202425SurgiLattice scaffoldTepha, Inc.K162922GalaFORM 3DTepha, Inc.K161424Phasix MeshC.R. Bard, Inc.K161092GalaSHAPE 3DTepha, Inc.K130326TEPHAFLEX MELTBLOWN CONSTRUCTTepha, 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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