510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161000Substantially Equivalent

Biodesign Otologic Repair Graft

Cook Biotech Incorporated, West Lafayette IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161000 is the FDA 510(k) clearance record for Biodesign Otologic Repair Graft, a class II device, cleared for Cook Biotech Incorporated on under FDA product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)). FDA records list 16 510(k) clearances for Cook Biotech Incorporated, from to . As of , FDA records show no recalls naming K161000.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Cook Biotech Incorporated 1425 Innovation Pl., West Lafayette IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHJ

Trailing 12 months
1 clearance under product code KHJ in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KHJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260