SILICONE-SILVER PENILE PROSTHESIS-ESK
FDA 510(k) clearance K830667 · decided 1983-10-20
Clearance details
- K-number
- K830667
- Device name
- SILICONE-SILVER PENILE PROSTHESIS-ESK
- Applicant
- Dacomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-04
- Decision date
- 1983-10-20
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- FTQ
- Device class
- 2
- Regulation number
- 876.3630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, 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 |
|---|---|---|
| VIRILIS PENILE PROSTHESIS (K983015) | Specialty Surgical Products, Inc. | 1999-02-05 |
Recalls involving this device
No recalls on record reference this clearance.