Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence
FDA 510(k) K970308 · Mentor Urology, Inc.
510(k) numberK970308
Submission
- Device name
- Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence
- Applicant
- Mentor Urology, Inc.
Minneapolis, MN, US - Received
- January 27, 1997
- Decision date
- April 2, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FHA – Clamp, Penile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5160
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974040 | C3 External Male Bladder Control DeviceFHA · Traditional | Timm Research Co. | 07/14/1998SE |
| K971992 | Uromed Alternative Bladder Control Continence DEVICE(ABCPN-0026)FHA · Traditional | Uromed Corp. | 08/01/1997SE |
| K964580 | Cap-Aid (Improved)FHA · Traditional | Nebel, Inc. | 01/10/1997SE |
| K955810 | U-TexFHA · Traditional | Laborie Medical Technologies, Ltd. | 01/24/1996SE |
| K954959 | Cap-AidFHA · Traditional | Nebl, Inc. | 12/06/1995SE |
| K952841 | The AssistantFHA · Traditional | Apple Medical Corp. | 08/18/1995SE |
| K896160 | Williams Penile Anesthetic RetainerFHA · Traditional | Cook Urological, Inc. | 02/16/1990SE |
| K885323 | Dacomed External Male Continence DeviceFHA · Traditional | Dacomed Corp. | 02/08/1989SE |
| K863227 | Cook-Vpi Continence CuffFHA · Traditional | Cook Urological, Inc. | 02/03/1987SE |
| K780137 | Clamp, Incontinence, BaumruckerFHA · Traditional | Greenwald Surgical Co., Inc. | 04/28/1978SE |
Questions and answers
When was Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence cleared by the FDA?
Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence (K970308) received a 510(k) decision of Substantially Equivalent on April 2, 1997, 65 days after the submission was received.
What is the product code of K970308?
The FDA product code is FHA – Clamp, Penile, a Class I (low risk) device regulated under 21 CFR 876.5160.