Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
FDA 510(k) clearance K232646 · decided 2024-05-24
Clearance details
- K-number
- K232646
- Device name
- Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
- Applicant
- Cook Biotech Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2023-08-30
- Decision date
- 2024-05-24
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- KHJ
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- West Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Biodesign Otologic Repair Graft (K161000) | Cook Biotech Incorporated | 2016-05-11 |
| Biodesign Otologic Repair Graft (K150594) | Cook Biotech Incorprated | 2015-09-16 |
| ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (K132198) | Ceremed , Inc. | 2013-09-12 |
| BIODESIGN ENT REPAIR GRAFT (K121360) | Cook Biotech Incorprated | 2013-02-27 |
| ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (K122561) | Ceremed , Inc. | 2012-11-27 |
| ADAPTAIN SOLUBLE IMPLANT MATERIAL (K120220) | Ceremed , Inc. | 2012-06-06 |
| CERETENE SOLUBLE IMPLANT MATERIAL (K103047) | Ceremed , Inc. | 2011-01-05 |
| GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (K080022) | Vascular Solutions, Inc. | 2008-12-09 |
| AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (K082245) | Ceremed , Inc. | 2008-09-18 |
| AOC SOLUBLE IMPLANT MATERIAL (K081531) | Ceremed , Inc. | 2008-07-18 |
| OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE (K070093) | Ceremed , Inc. | 2007-01-24 |
| OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE (K062280) | Ceremed , Inc. | 2006-12-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Ste recall (Z-0832-2025) | Cook Biotech, Inc. | 2025-01-10 |