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FDA 510(k)

Biodesign Otologic Repair Graft

K-Number: K161000 · 2016-05-11

ApplicantCook Biotech Incorporated
Decision Date2016-05-11
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Biodesign Otologic Repair Graft is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-05-11 under 510(k) number K161000. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biodesign Otologic Repair Graft?

Biodesign Otologic Repair Graft is a medical device that received FDA 510(k) clearance on 2016-05-11. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K161000.

When did Biodesign Otologic Repair Graft receive FDA 510(k) clearance?

Biodesign Otologic Repair Graft received FDA 510(k) clearance on 2016-05-11, under 510(k) number K161000.

Who is the listed applicant for Biodesign Otologic Repair Graft?

The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodesign Otologic Repair Graft?

The FDA product code for Biodesign Otologic Repair Graft is KHJ.

Other records listing Cook Biotech Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)K201000Biodesign Staple Line ReinforcementK191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftK171817Biodesign Diaphragmatic Hernia GraftK162934Biodesign Parastomal Hernia Repair GraftK170016Biodesign Fistula Plug

View all 13 devices →

Related Devices (Code: KHJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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