LKY · Device, External Penile Rigidity
Gastroenterology, Urology · 21 CFR 876.5020 · Class 2
Overview
| Product Code | LKY |
|---|---|
| Device Name | Device, External Penile Rigidity |
| Regulation | 21 CFR 876.5020 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.
Classification Rationale
Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 87)
Showing 20 most recent of 87 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | Nanma Mfg Co., Ltd. | Aug 25, 2004 | SESE |
| K032776 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | Oct 3, 2003 | SESE |
| K030119 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | Aug 6, 2003 | SESE |
| K030913 | NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | Jun 3, 2003 | SESE |
| K013113 | MODIFICATION TO NANMA VACUUM PUMP | Nanma Mfg Co., Ltd. | Dec 20, 2002 | SESE |
| K013051 | NANMA ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | Aug 22, 2002 | SESE |
| K020969 | VACURECT VACUUM CONSTRICTION DEVICE | Vacurect Manufacturing (Pty) , Ltd. | Jun 5, 2002 | SESE |
| K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | Nanma Mfg Co., Ltd. | May 9, 2002 | SESE |
| K020258 | SUPPORT SLEEVE | Pos-T-Vac, Inc. | Apr 4, 2002 | SESE |
| K020154 | VT-1 | Pos-T-Vac, Inc. | Apr 4, 2002 | SESE |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM | Endocare, Inc. | Feb 5, 2002 | SESE |
| K012672 | BOSS-2000-2 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | Nov 9, 2001 | SESE |
| K012670 | BOSS 2000-3 VACUUM ERECTION DEVICE | Pos-T-Vac, Inc. | Nov 9, 2001 | SESE |
| K012662 | SE-100 VACUUM ERECTION DEVICE | Vts, Inc. | Nov 9, 2001 | SESE |
| K012639 | SE-300 VACUUM THERAPY SYSTEM | Vts, Inc. | Nov 9, 2001 | SESE |
| K012620 | SE-200 | Vts, Inc. | Nov 9, 2001 | SESE |
| K012619 | VT-1 | Vts, Inc. | Nov 9, 2001 | SESE |
| K001859 | PENILE CONSTRICTOR RING | Basic Solutions, LLC | Jan 11, 2001 | SESE |
| K003115 | ACTIS ADJUSTABLE CONSTRICTION LOOP | Vivus, Inc. | Dec 19, 2000 | SESE |
| K000730 | IMPOAID | Impoaid, Inc. | Oct 19, 2000 | SESE |
Top Applicants
- Pos-T-Vac, Inc. — 11 clearances
- Nanma Mfg Co., Ltd. — 9 clearances
- Ercons, Inc. — 6 clearances
- Vts, Inc. — 5 clearances
- Walling Medical Equipment Co. — 4 clearances
