Nanma Adjustable Constriction Ring
FDA 510(k) K013051 · Nanma Mfg Co., Ltd.
510(k) numberK013051
Submission
- Device name
- Nanma Adjustable Constriction Ring
- Applicant
- Nanma Mfg Co., Ltd.
Crofton, MD, US - Received
- September 11, 2001
- Decision date
- August 22, 2002
- 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 |
| 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 |
| K020082 | Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery SystemLKY · Special | Endocare, Inc. | 02/05/2002SE |
More from Endocare, 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 |
| K013053 | Modification to Nanma Non-Adjustable Constriction RingLKY · Traditional | 05/09/2002SE |
| K993909 | Nanma Vacuum PumpLKY · Traditional | 07/19/2000SE |
| 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 Adjustable Constriction Ring cleared by the FDA?
Nanma Adjustable Constriction Ring (K013051) received a 510(k) decision of Substantially Equivalent on August 22, 2002, 345 days after the submission was received.
What is the product code of K013051?
The FDA product code is LKY – Device, External Penile Rigidity, a Class II (moderate risk) device regulated under 21 CFR 876.5020.