Medical Device Manufacturer · US , Cambridge , MA

Tepha, Inc. - FDA 510(k) Cleared Devices

18 submissions · 17 cleared · Since 2007

Recent clearances: GalaFLEX LITE Scaffold, SurgiLattice scaffold, GalaSTITCH Absorbable Monofilament Suture

18
Total
17
Cleared
1
Denied

FDA 510(k) Regulatory Record - Tepha, Inc. General & Plastic Surgery ✕

18 devices
1-12 of 18
Cleared Apr 09, 2024
GalaFLEX LITE Scaffold
K233999 · OOD
General & Plastic Surgery · 113d
Cleared Aug 19, 2021
SurgiLattice scaffold
K202425 · OOD
General & Plastic Surgery · 359d
Cleared May 27, 2021
GalaSTITCH Absorbable Monofilament Suture
K211307 · NWJ
General & Plastic Surgery · 28d
Cleared Feb 23, 2017
GalaFORM 3D
K162922 · OOD
General & Plastic Surgery · 128d
Cleared Aug 23, 2016
GalaSHAPE 3D
K161092 · OOD
General & Plastic Surgery · 127d
Cleared May 21, 2014
GALAFLEX MESH
K140533 · OOD
General & Plastic Surgery · 78d
Cleared Sep 05, 2013
TEPHAFLEX BRAIDED SUTURE
K132348 · NWJ
General & Plastic Surgery · 38d
Cleared May 07, 2013
TEPHAFLEX MELTBLOWN CONSTRUCT
K130326 · OOD
General & Plastic Surgery · 88d
Cleared Feb 15, 2012
TEPHAFLEX LIGHT MESH
K113721 · OOD
General & Plastic Surgery · 58d
Cleared Feb 15, 2012
TEPHAFLEX MESH
K113723 · OOD
General & Plastic Surgery · 58d
Cleared Sep 26, 2011
TEPHAFLEX MESH
K111946 · OOD
General & Plastic Surgery · 80d
Cleared Aug 30, 2010
TEPHAFLEX COMPOSITE MESH
K101287 · OWT
General & Plastic Surgery · 115d
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