ePTFE-Coated Auricular Implant
FDA 510(k) clearance K172389 · decided 2018-07-18
Clearance details
- K-number
- K172389
- Device name
- ePTFE-Coated Auricular Implant
- Applicant
- Implantech Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-08
- Decision date
- 2018-07-18
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- FZD
- Device class
- 2
- Regulation number
- 878.3590
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ventura, CA, 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 |
|---|---|---|
| POREX(TM) EAR PROSTHESIS (K863939) | Porex Medical | 1986-10-24 |
| CANAL WALL PROSTHESIS (K844960) | Richards Medical Co., Inc. | 1985-02-26 |
Recalls involving this device
No recalls on record reference this clearance.