K013113 is an FDA 510(k) clearance for the MODIFICATION TO NANMA VACUUM PUMP. This device is classified as a Device, External Penile Rigidity (Class II — Special Controls, product code LKY).
Submitted by Nanma Mfg Co., Ltd. (Crofton, US). The FDA issued a Cleared decision on December 20, 2002, 458 days after receiving the submission on September 18, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5020. 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..
| 510(k) Number | K013113 FDA.gov |
| FDA Decision | Cleared () |
| Date Received | September 18, 2001 |
| Decision Date | December 20, 2002 |
| Days to Decision | 458 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LKY — Device, External Penile Rigidity |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5020 |
| 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. |