510(k) K955856
K955856 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies, Ltd. for the device "TEX-AID BLUE". The FDA issued a decision of Substantially Equivalent on February 16, 1996. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Laborie Medical Technologies, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1996
- Date Received
- December 26, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, External Penile Rigidity
- Device Class
- Class II
- Regulation Number
- 876.5020
- Review Panel
- GU
- Submission Type
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.