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FDA 510(k)

GalaSHAPE 3D

K-Number: K161092 · 2016-08-23

ApplicantTepha, Inc.
Decision Date2016-08-23
Product CodeOOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GalaSHAPE 3D is a medical device manufactured by Tepha, Inc.. It received FDA 510(k) clearance on 2016-08-23 under approval number K161092. 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 GalaSHAPE 3D?

GalaSHAPE 3D is a medical device that received FDA 510(k) clearance on 2016-08-23. It is manufactured by Tepha, Inc.. The 510(k) number is K161092.

When was GalaSHAPE 3D approved by the FDA?

GalaSHAPE 3D received FDA 510(k) clearance on 2016-08-23, under approval number K161092.

What company makes GalaSHAPE 3D?

GalaSHAPE 3D is manufactured by Tepha, Inc..

What is the FDA product code for GalaSHAPE 3D?

The FDA product code for GalaSHAPE 3D is OOD.

Other Devices by Tepha, Inc.

K162922GalaFORM 3D K202425SurgiLattice scaffold K211307GalaSTITCH Absorbable Monofilament Suture K233999GalaFLEX LITE Scaffold

Related Devices (Code: OOD)

K161424Phasix MeshC.R. Bard, Inc. K162922GalaFORM 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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