K980291 is an FDA 510(k) clearance for the IMPOWER EXTERNAL VACUUM SYSTEM. This device is classified as a Device, External Penile Rigidity (Class II — Special Controls, product code LKY).
Submitted by Imagyn Medical Technologies, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on March 11, 1998, 44 days after receiving the submission on January 26, 1998.
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 | K980291 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 1998 |
| Decision Date | March 11, 1998 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |