FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Biodesign Otologic Repair Graft
K Number: K150594
·
Decision Sep 16, 2015
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
4
Review Days
191
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Basic Information
- Device Name
- Biodesign Otologic Repair Graft
- K Number
- K150594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Biotech Incorprated
- Date Received
- March 9, 2015
- Decision Date
- September 16, 2015
- Product Code
- KHJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHJ), ordered by most recent decision date.
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
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Biodesign Otologic Repair Graft
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ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
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BIODESIGN ENT REPAIR GRAFT
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ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
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ADAPTAIN SOLUBLE IMPLANT MATERIAL
FDA 510(k)
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·Ear, Nose, Throat