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FDA 510(k)

GalaFORM 3D

K-Number: K162922 · 2017-02-23

ApplicantTepha, Inc.
Decision Date2017-02-23
Product CodeOOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GalaFORM 3D is a medical device manufactured by Tepha, Inc.. It received FDA 510(k) clearance on 2017-02-23 under approval 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. It is manufactured by Tepha, Inc.. The 510(k) number is K162922.

When was GalaFORM 3D approved by the FDA?

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

What company makes GalaFORM 3D?

GalaFORM 3D is manufactured by Tepha, Inc..

What is the FDA product code for GalaFORM 3D?

The FDA product code for GalaFORM 3D is OOD.

Other Devices by Tepha, Inc.

K161092GalaSHAPE 3D K202425SurgiLattice scaffold K211307GalaSTITCH Absorbable Monofilament Suture K233999GalaFLEX LITE Scaffold

Related Devices (Code: OOD)

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