510(k) K161092

GalaSHAPE 3D by Tepha, Inc. — Product Code OOD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 23, 2016
Date Received: April 18, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Surgical Film
Device Class: Class II
Regulation Number: 878.3300
Review Panel: SU
Submission Type

To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.

Other clearances by Tepha, Inc.

K233999 — GalaFLEX LITE Scaffold (April 9, 2024)
K202425 — SurgiLattice scaffold (August 19, 2021)
K211307 — GalaSTITCH Absorbable Monofilament Suture (May 27, 2021)
K162922 — GalaFORM 3D (February 23, 2017)
K140533 — GALAFLEX MESH (May 21, 2014)
K132348 — TEPHAFLEX BRAIDED SUTURE (September 5, 2013)
K130326 — TEPHAFLEX MELTBLOWN CONSTRUCT (May 7, 2013)
K113721 — TEPHAFLEX LIGHT MESH (February 15, 2012)
K113723 — TEPHAFLEX MESH (February 15, 2012)
K111946 — TEPHAFLEX MESH (September 26, 2011)

Other clearances for product code OOD

K233999 — GalaFLEX LITE Scaffold (April 9, 2024)
K202425 — SurgiLattice scaffold (August 19, 2021)
K162922 — GalaFORM 3D (February 23, 2017)
K161424 — Phasix Mesh (September 29, 2016)
K142818 — Phasix Mesh (March 31, 2015)
K140533 — GALAFLEX MESH (May 21, 2014)
K130326 — TEPHAFLEX MELTBLOWN CONSTRUCT (May 7, 2013)
K113723 — TEPHAFLEX MESH (February 15, 2012)
K113721 — TEPHAFLEX LIGHT MESH (February 15, 2012)
K111946 — TEPHAFLEX MESH (September 26, 2011)