Submission Details
| 510(k) Number | K161000 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2016 |
| Decision Date | May 11, 2016 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Special
Biodesign Otologic Repair Graft
May 2016
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K161000 is an FDA 510(k) clearance for the Biodesign Otologic Repair Graft, a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II — Special Controls, product code KHJ), submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on May 11, 2016, 30 days after receiving the submission on April 11, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.
Device Classification
| Product Code | KHJ — Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |
Manufacturer
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