DUNA II PENILE PROSTHESIS
FDA 510(k) clearance K953640 · decided 1995-10-27
Clearance details
- K-number
- K953640
- Device name
- DUNA II PENILE PROSTHESIS
- Applicant
- Dacomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-04
- Decision date
- 1995-10-27
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FAE
- Device class
- 2
- Regulation number
- 876.3630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dacomed Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, recall (Z-0702-2007) | American Medical Systems | 2007-04-03 |
| AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical System recall (Z-0703-2007) | American Medical Systems | 2007-04-03 |