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FDA 510(k)

SurgiLattice scaffold

K-Number: K202425 · 2021-08-19

ApplicantTepha, Inc.
Decision Date2021-08-19
Product CodeOOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SurgiLattice scaffold is a medical device manufactured by Tepha, Inc.. It received FDA 510(k) clearance on 2021-08-19 under approval 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. It is manufactured by Tepha, Inc.. The 510(k) number is K202425.

When was SurgiLattice scaffold approved by the FDA?

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

What company makes SurgiLattice scaffold?

SurgiLattice scaffold is manufactured by Tepha, Inc..

What is the FDA product code for SurgiLattice scaffold?

The FDA product code for SurgiLattice scaffold is OOD.

Other Devices by Tepha, Inc.

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

Related Devices (Code: OOD)

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