Sensation -Vacuum Assist Devices
FDA 510(k) K000124 · Prosurg, Inc.
510(k) numberK000124
Submission
- Device name
- Sensation -Vacuum Assist Devices
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- January 18, 2000
- Decision date
- July 10, 2000
- 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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| K152466 | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)EOQ · Traditional | 05/19/2016SE |
| K152619 | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)GCJ · Traditional | 04/29/2016SE |
| K120766 | Endoscopic Diagnostic & Treatment System (Modification)FAJ · Traditional | 09/11/2012SE |
| K072528 | Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & AccessoriesJEY · Traditional | 12/28/2007SE |
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| K070737 | Xsorb Bioabsorbable Craniofacial Bone Fixation System & AccessoriesJEY · Traditional | 07/25/2007SE |
| K070846 | Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemFTL · Traditional | 07/02/2007SE |
| K060326 | Lasertx - Diode Laser & Delivery SystemGEX · Traditional | 04/05/2006SE |
| K050488 | Turbt-Rf Electrodes and Electrosurgical DevicesFAS · Traditional | 04/01/2005SE |
Questions and answers
When was Sensation -Vacuum Assist Devices cleared by the FDA?
Sensation -Vacuum Assist Devices (K000124) received a 510(k) decision of Substantially Equivalent on July 10, 2000, 174 days after the submission was received.
What is the product code of K000124?
The FDA product code is LKY – Device, External Penile Rigidity, a Class II (moderate risk) device regulated under 21 CFR 876.5020.