FDA 510(k)

GalaFLEX LITE Scaffold

K-Number: K233999 · 2024-04-09

Decision Date2024-04-09

Product CodeOOD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GalaFLEX LITE Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2024-04-09 under 510(k) number K233999. 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 GalaFLEX LITE Scaffold?

GalaFLEX LITE Scaffold is a medical device that received FDA 510(k) clearance on 2024-04-09. The listed applicant is Tepha, Inc.. The 510(k) number is K233999.

When did GalaFLEX LITE Scaffold receive FDA 510(k) clearance?

GalaFLEX LITE Scaffold received FDA 510(k) clearance on 2024-04-09, under 510(k) number K233999.

Who is the listed applicant for GalaFLEX LITE Scaffold?

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 GalaFLEX LITE Scaffold?

The FDA product code for GalaFLEX LITE Scaffold 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.

K202425SurgiLattice scaffold K211307GalaSTITCH Absorbable Monofilament Suture K162922GalaFORM 3D K161092GalaSHAPE 3D

Related Devices (Code: OOD)

K202425SurgiLattice scaffoldTepha, Inc.K162922GalaFORM 3DTepha, 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.