K030119 is an FDA 510(k) clearance for the NANMA ADJUSTABLE CONSTRICTION RING. 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 August 6, 2003, 205 days after receiving the submission on January 13, 2003.
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 | K030119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2003 |
| Decision Date | August 06, 2003 |
| Days to Decision | 205 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. |