K900774 is an FDA 510(k) clearance for the DACOMED NEGATIVE PRESSURE 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 4, 1990, 73 days after receiving the submission on February 20, 1990.
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 | K900774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1990 |
| Decision Date | May 04, 1990 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| 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. |