K955856 is an FDA 510(k) clearance for the TEX-AID BLUE. This device is classified as a Device, External Penile Rigidity (Class II - Special Controls, product code LKY).
Submitted by Laborie Medical Technologies, Ltd. (Mississauga Ont. Canada, CA). The FDA issued a Cleared decision on February 16, 1996, 52 days after receiving the submission on December 26, 1995.
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 | K955856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1995 |
| Decision Date | February 16, 1996 |
| Days to Decision | 52 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. |