MNG · External Urethral Occluder, Urinary Incontinence-Control, Female
Gastroenterology, Urology · 21 CFR 876.5160 · Class 1
Overview
| Product Code | MNG |
|---|---|
| Device Name | External Urethral Occluder, Urinary Incontinence-Control, Female |
| Regulation | 21 CFR 876.5160 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.
Classification Rationale
Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Personal Products Co. | Apr 30, 2001 | SESE |
| K983164 | RESTORE (AKA RE/STOR) | Nebl, Inc. | Mar 5, 1999 | SESE |
| K974600 | UROMED PATCH | Uromed Corp. | Mar 31, 1998 | SESE |
| K974645 | FEMASSIST FLEXIBLE | Insight Medical Corp. | Feb 12, 1998 | SESE |
| K971359 | RESTORE (A.K.A. CAPSURE) | Nebl, Inc. | Nov 14, 1997 | SESE |
| K963858 | FEMASSIST URINARY DEVICE | Insight Medical Corp. | Oct 21, 1997 | SESE |
| K954215 | MINIGUARD | Advanced Surgical Intervention, Inc. | May 8, 1996 | SESE |
Top Applicants
- Insight Medical Corp. — 2 clearances
- Nebl, Inc. — 2 clearances
- Advanced Surgical Intervention, Inc. — 1 clearance
- Personal Products Co. — 1 clearance
- Uromed Corp. — 1 clearance
