Impower External Vacuum System
FDA 510(k) K980291 · Imagyn Medical Technologies, Inc.
510(k) numberK980291
Submission
- Device name
- Impower External Vacuum System
- Applicant
- Imagyn Medical Technologies, Inc.
Laguna Niguel, CA, US - Received
- January 26, 1998
- Decision date
- March 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
More from Pos-T-Vac, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032491 | Ecom CV4 Endotracheal Cardiac Output MonitorDSB · Special | 09/04/2003SESU |
| K012706 | IM2001 Pulse OximeterDQA · Traditional | 03/07/2003SE |
| K010166 | Imagyn Isosleeve / Isostar Needle SystemIWJ · Traditional | 12/03/2001SE |
| K991526 | Isostar I-125 Interstitial Seed, Model IS-12501KXK · Special | 06/17/1999SE |
| K980096 | Oac (Optical Aspirating Curette)HCY · Traditional | 05/01/1998SE |
| K974173 | Erecaid System/Stay Erec SystemLKY · Traditional | 02/25/1998SE |
Questions and answers
When was Impower External Vacuum System cleared by the FDA?
Impower External Vacuum System (K980291) received a 510(k) decision of Substantially Equivalent on March 11, 1998, 44 days after the submission was received.
What is the product code of K980291?
The FDA product code is LKY – Device, External Penile Rigidity, a Class II (moderate risk) device regulated under 21 CFR 876.5020.