FDA 510(k)

GalaFORM 3D

K-Number: K162922 · 2017-02-23

Decision Date2017-02-23

Product CodeOOD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GalaFORM 3D is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K162922. 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 GalaFORM 3D?

GalaFORM 3D is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Tepha, Inc.. The 510(k) number is K162922.

When did GalaFORM 3D receive FDA 510(k) clearance?

GalaFORM 3D received FDA 510(k) clearance on 2017-02-23, under 510(k) number K162922.

Who is the listed applicant for GalaFORM 3D?

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 GalaFORM 3D?

The FDA product code for GalaFORM 3D is OOD.

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 Scaffold K202425SurgiLattice scaffold K211307GalaSTITCH Absorbable Monofilament Suture K161092GalaSHAPE 3D

Related Devices (Code: OOD)

K233999GalaFLEX LITE ScaffoldTepha, Inc.K202425SurgiLattice scaffoldTepha, Inc.K161424Phasix MeshC.R. Bard, Inc.K161092GalaSHAPE 3DTepha, 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.