LKY — Device, External Penile Rigidity Class II
FDA product code LKY covers "Device, External Penile Rigidity", a Class II medical device regulated under 21 CFR 876.5020. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKY
- Device Class
- Class II
- Regulation Number
- 876.5020
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K041573 | nanma mfg co | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | August 25, 2004 |
| K032776 | vacurect manufacturing (pty) | VACURECT VACUUM CONSTRICTION DEVICE | October 3, 2003 |
| K030119 | nanma mfg co | NANMA ADJUSTABLE CONSTRICTION RING | August 6, 2003 |
| K030913 | nanma mfg co | NANMA VACUUM PUMP | June 3, 2003 |
| K013113 | nanma mfg co | MODIFICATION TO NANMA VACUUM PUMP | December 20, 2002 |
| K013051 | nanma mfg co | NANMA ADJUSTABLE CONSTRICTION RING | August 22, 2002 |
| K020969 | vacurect manufacturing (pty) | VACURECT VACUUM CONSTRICTION DEVICE | June 5, 2002 |
| K013053 | nanma mfg co | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | May 9, 2002 |
| K020154 | pos-t-vac | VT-1 | April 4, 2002 |
| K020258 | pos-t-vac | SUPPORT SLEEVE | April 4, 2002 |
| K020082 | endocare | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYS | February 5, 2002 |
| K012670 | pos-t-vac | BOSS 2000-3 VACUUM ERECTION DEVICE | November 9, 2001 |
| K012662 | vts | SE-100 VACUUM ERECTION DEVICE | November 9, 2001 |
| K012672 | pos-t-vac | BOSS-2000-2 VACUUM ERECTION DEVICE | November 9, 2001 |
| K012639 | vts | SE-300 VACUUM THERAPY SYSTEM | November 9, 2001 |
| K012619 | vts | VT-1 | November 9, 2001 |
| K012620 | vts | SE-200 | November 9, 2001 |
| K001859 | basic solutions | PENILE CONSTRICTOR RING | January 11, 2001 |
| K003115 | vivus | ACTIS ADJUSTABLE CONSTRICTION LOOP | December 19, 2000 |
| K000730 | impoaid | IMPOAID | October 19, 2000 |