Tex-Aid Blue
FDA 510(k) K955856 · Laborie Medical Technologies, Ltd.
510(k) numberK955856
Submission
- Device name
- Tex-Aid Blue
- Applicant
- Laborie Medical Technologies, Ltd.
Mississauga Ont. Canada, CA - Received
- December 26, 1995
- Decision date
- February 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKY – Device, External Penile Rigidity
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5020
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code LKY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041573 | Nanma Vacuum Pump Proxzek Model 2M9498SLKY · Traditional | Nanma Mfg Co., Ltd. | 08/25/2004SE |
| K032776 | Vacurect Vacuum Constriction DeviceLKY · Traditional | Vacurect Manufacturing (Pty) , Ltd. | 10/03/2003SE |
| K030119 | Nanma Adjustable Constriction RingLKY · Traditional | Nanma Mfg Co., Ltd. | 08/06/2003SE |
| K030913 | Nanma Vacuum PumpLKY · Traditional | Nanma Mfg Co., Ltd. | 06/03/2003SE |
| K013113 | Modification to Nanma Vacuum PumpLKY · Traditional | Nanma Mfg Co., Ltd. | 12/20/2002SE |
| K013051 | Nanma Adjustable Constriction RingLKY · Traditional | Nanma Mfg Co., Ltd. | 08/22/2002SE |
| K020969 | Vacurect Vacuum Constriction DeviceLKY · Traditional | Vacurect Manufacturing (Pty) , Ltd. | 06/05/2002SE |
| K013053 | Modification to Nanma Non-Adjustable Constriction RingLKY · Traditional | Nanma Mfg Co., Ltd. | 05/09/2002SE |
| K020258 | Support SleeveLKY · Traditional | Pos-T-Vac, Inc. | 04/04/2002SE |
| K020154 | VT-1LKY · Traditional | Pos-T-Vac, Inc. | 04/04/2002SE |
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| K240007 | Solar Compact (G4-1)FFX · Traditional | 05/06/2024SE |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)KLA · Traditional | 04/23/2024SE |
| K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipFBK · Traditional | 07/21/2009SE |
| K082614 | Evox Electro Diagnostic DeviceGWF · Traditional | 03/06/2009SE |
| K081781 | NuwavIYO · Traditional | 07/09/2008SE |
| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | 03/05/2008SE |
| K070331 | Urostym Biofeedback and Stimulation Device and AccessoriesKPI · Traditional | 05/04/2007SE |
| K962009 | UrostymKPI · Traditional | 05/20/1997SE |
| K955810 | U-TexFHA · Traditional | 01/24/1996SE |
Questions and answers
When was Tex-Aid Blue cleared by the FDA?
Tex-Aid Blue (K955856) received a 510(k) decision of Substantially Equivalent on February 16, 1996, 52 days after the submission was received.
What is the product code of K955856?
The FDA product code is LKY – Device, External Penile Rigidity, a Class II (moderate risk) device regulated under 21 CFR 876.5020.