K920409 is an FDA 510(k) clearance for the DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE. This device is classified as a Device, External Penile Rigidity (Class II — Special Controls, product code LKY).
Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on May 11, 1992, 101 days after receiving the submission on January 31, 1992.
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 | K920409 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 31, 1992 |
| Decision Date | May 11, 1992 |
| Days to Decision | 101 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. |