Data / Medical devices / United States / Tepha, Incorporated

Tepha, Incorporated: FDA-registered device maker in Lexington, MA, United States, 4 510(k) clearances

Name: Tepha, Incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tepha, Incorporated is registered with the FDA (registration 3005670760) in Lexington, MA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated April 9, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005670760
Address: 99 Hayden Avenue, Suite 360, Lexington, MA, United States, 02421
Owner or operator: Tepha Inc. (10023049)
Roles: Manufacturer, Specification developer
First device listed: December 17, 2015
Registered through: 2027
Brand names listed: GalaFLEX, GalaFLEX 3D, GalaFLEX 3DR, GalaFLEX LITE

Devices it lists

Device	Product code	Class	Role	Source
Surgical Film	OOD	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 9, 2024	K233999	GalaFLEX LITE Scaffold	OOD	Substantially Equivalent	Tepha, Inc.	accessdata.fda.gov
February 23, 2017	K162922	GalaFORM 3D	OOD	Substantially Equivalent	Tepha, Inc.	accessdata.fda.gov
August 23, 2016	K161092	GalaSHAPE 3D	OOD	Substantially Equivalent	Tepha, Inc.	accessdata.fda.gov
May 21, 2014	K140533	GALAFLEX MESH	OOD	Substantially Equivalent	Tepha, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 21, 2016	75827	Class II	Terminated	GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist	Endotoxin values from testing of retains slightly exceeded the established specification.	accessdata.fda.gov

Compare with other makers

All makers of Surgical Film

Updated April 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.