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510(k) K232646

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) by Cook Biotech Incorporated — Product Code KHJ

K232646 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)". The FDA issued a decision of Substantially Equivalent on May 24, 2024. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Cook Biotech Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2024
Date Received
August 30, 2023
Clearance Type
Traditional
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

  • 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)
  • K161221 — Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (May 26, 2016)

Other clearances for product code KHJ

  • K161000 — Biodesign Otologic Repair Graft (May 11, 2016)
  • 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)

FDA data resources