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510(k) K211307

GalaSTITCH Absorbable Monofilament Suture by Tepha, Inc. — Product Code NWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2021
Date Received
April 29, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Recombinant Technology
Device Class
Class II
Regulation Number
878.4494
Review Panel
SU
Submission Type

Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.

Other clearances by Tepha, Inc.

  • K233999 — GalaFLEX LITE Scaffold (April 9, 2024)
  • K202425 — SurgiLattice scaffold (August 19, 2021)
  • K162922 — GalaFORM 3D (February 23, 2017)
  • K161092 — GalaSHAPE 3D (August 23, 2016)
  • 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 NWJ

  • K132348 — TEPHAFLEX BRAIDED SUTURE (September 5, 2013)
  • K130422 — PHANTOM FIBER BIOFIBER SUTURE (April 4, 2013)
  • K122487 — BIOFIBER SYTURE (September 17, 2012)
  • K100876 — AESCULAP MONOMAX ABSORBABLE SUTURE (July 14, 2010)
  • K082178 — TEPHAFLEX ABSORBABLE SUTURE (October 30, 2008)
  • K081099 — TEPHAFLEX ABSORBABLE SUTURE (July 15, 2008)
  • K072470 — BIOELAST 5-0 SUTURE, MODEL 500100 (November 16, 2007)
  • DEN060003 — TEPHAFLEX ABSORBABLE SUTURE (February 8, 2007)