FDA 510(k)

SurgiLattice scaffold

K-Number: K202425 · 2021-08-19

Decision Date2021-08-19

Product CodeOOD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SurgiLattice 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 2021-08-19 under 510(k) number K202425. 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 SurgiLattice scaffold?

SurgiLattice scaffold is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Tepha, Inc.. The 510(k) number is K202425.

When did SurgiLattice scaffold receive FDA 510(k) clearance?

SurgiLattice scaffold received FDA 510(k) clearance on 2021-08-19, under 510(k) number K202425.

Who is the listed applicant for SurgiLattice 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 SurgiLattice scaffold?

The FDA product code for SurgiLattice 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.

K233999GalaFLEX LITE Scaffold K211307GalaSTITCH Absorbable Monofilament Suture K162922GalaFORM 3D K161092GalaSHAPE 3D

Related Devices (Code: OOD)

K233999GalaFLEX LITE 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.