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FDA 510(k)

GalaFLEX LITE Scaffold

K-Number: K233999 · 2024-04-09

ApplicantTepha, Inc.
Decision Date2024-04-09
Product CodeOOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GalaFLEX LITE Scaffold is a medical device manufactured by Tepha, Inc.. It received FDA 510(k) clearance on 2024-04-09 under approval 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. It is manufactured by Tepha, Inc.. The 510(k) number is K233999.

When was GalaFLEX LITE Scaffold approved by the FDA?

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

What company makes GalaFLEX LITE Scaffold?

GalaFLEX LITE Scaffold is manufactured by Tepha, Inc..

What is the FDA product code for GalaFLEX LITE Scaffold?

The FDA product code for GalaFLEX LITE Scaffold is OOD.

Related Clinical Trials

NCT05945329 Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation RECRUITING

Other Devices by Tepha, Inc.

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

Related Devices (Code: OOD)

K161424Phasix MeshC.R. Bard, Inc. K161092GalaSHAPE 3DTepha, Inc. K162922GalaFORM 3DTepha, Inc. K202425SurgiLattice 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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