FDA 510(k)

GalaSHAPE 3D

K-Number: K161092 · 2016-08-23

Decision Date2016-08-23

Product CodeOOD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GalaSHAPE 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 2016-08-23 under 510(k) 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. The listed applicant is Tepha, Inc.. The 510(k) number is K161092.

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

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

Who is the listed applicant for GalaSHAPE 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 GalaSHAPE 3D?

The FDA product code for GalaSHAPE 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 K162922GalaFORM 3D

Related Devices (Code: OOD)

K233999GalaFLEX LITE ScaffoldTepha, Inc.K202425SurgiLattice scaffoldTepha, Inc.K162922GalaFORM 3DTepha, Inc.K161424Phasix MeshC.R. Bard, 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.