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510(k) K121360

BIODESIGN ENT REPAIR GRAFT by Cook Biotech Incorprated — Product Code KHJ

K121360 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorprated for the device "BIODESIGN ENT REPAIR GRAFT". The FDA issued a decision of Substantially Equivalent on February 27, 2013. 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 Incorprated has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2013
Date Received
May 7, 2012
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 Incorprated

  • K150668 — Biodesign Enterocutaneous Fistula Plug (December 9, 2015)
  • K142887 — SIS Inguinal Hernia Repair Graft (October 1, 2015)
  • K150594 — Biodesign Otologic Repair Graft (September 16, 2015)

Other clearances for product code KHJ

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • 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)
  • 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