K020969 is an FDA 510(k) clearance for the VACURECT VACUUM CONSTRICTION DEVICE. This device is classified as a Device, External Penile Rigidity (Class II - Special Controls, product code LKY).
Submitted by Vacurect Manufacturing (Pty) , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on June 5, 2002, 71 days after receiving the submission on March 26, 2002.
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 | K020969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2002 |
| Decision Date | June 05, 2002 |
| Days to Decision | 71 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. |