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510(k) K161000

Biodesign Otologic Repair Graft by Cook Biotech Incorporated — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2016
Date Received
April 11, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Cook Biotech Incorporated

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • K201000 — Biodesign Staple Line Reinforcement (July 13, 2020)
  • K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery M (December 27, 2019)
  • K171817 — Biodesign Diaphragmatic Hernia Graft (March 13, 2018)
  • K162934 — Biodesign Parastomal Hernia Repair Graft (July 10, 2017)
  • K170016 — Biodesign Fistula Plug (June 21, 2017)
  • K170945 — Biodesign Staple Line Reinforcement (April 28, 2017)
  • K161762 — DynaMatrix/Dynamatrix Plus (January 13, 2017)
  • K162741 — AxoGuard Nerve Connector (October 31, 2016)
  • K160136 — Flowable Wound Matrix (September 28, 2016)

Other clearances for product code KHJ

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • K150594 — Biodesign Otologic Repair Graft (September 16, 2015)
  • K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (September 12, 2013)
  • K121360 — BIODESIGN ENT REPAIR GRAFT (February 27, 2013)
  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIAL (June 6, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (December 9, 2008)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)
  • K081531 — AOC SOLUBLE IMPLANT MATERIAL (July 18, 2008)