Nanma Vacuum Pump
FDA 510(k) K993909 · Nanma Mfg Co., Ltd.
510(k) numberK993909
Submission
- Device name
- Nanma Vacuum Pump
- Applicant
- Nanma Mfg Co., Ltd.
Crofton, MD, US - Received
- November 17, 1999
- Decision date
- July 19, 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 |
More from Pos-T-Vac, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K041573 | Nanma Vacuum Pump Proxzek Model 2M9498SLKY · Traditional | 08/25/2004SE |
| K030119 | Nanma Adjustable Constriction RingLKY · Traditional | 08/06/2003SE |
| K030913 | Nanma Vacuum PumpLKY · Traditional | 06/03/2003SE |
| K013113 | Modification to Nanma Vacuum PumpLKY · Traditional | 12/20/2002SE |
| K013051 | Nanma Adjustable Constriction RingLKY · Traditional | 08/22/2002SE |
| K013053 | Modification to Nanma Non-Adjustable Constriction RingLKY · Traditional | 05/09/2002SE |
| K993908 | Nanma Ajustable Constriction RingLKY · Traditional | 01/31/2000SE |
| K993906 | Nanma Non-Adjustable Constriction RingLKY · Traditional | 01/31/2000SE |
Questions and answers
When was Nanma Vacuum Pump cleared by the FDA?
Nanma Vacuum Pump (K993909) received a 510(k) decision of Substantially Equivalent on July 19, 2000, 245 days after the submission was received.
What is the product code of K993909?
The FDA product code is LKY – Device, External Penile Rigidity, a Class II (moderate risk) device regulated under 21 CFR 876.5020.