Cook-Vpi Continence Cuff
FDA 510(k) K863227 · Cook Urological, Inc.
510(k) numberK863227
Submission
- Device name
- Cook-Vpi Continence Cuff
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- August 21, 1986
- Decision date
- February 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K970308 | Mentor Urology Triple Rib Occlusion Wrap for Male IncontinenceFHA · Traditional | Mentor Urology, Inc. | 04/02/1997SE |
| 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 |
| K780137 | Clamp, Incontinence, BaumruckerFHA · Traditional | Greenwald Surgical Co., Inc. | 04/28/1978SE |
More from Greenwald Surgical Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | 05/06/2011SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
Questions and answers
When was Cook-Vpi Continence Cuff cleared by the FDA?
Cook-Vpi Continence Cuff (K863227) received a 510(k) decision of Substantially Equivalent on February 3, 1987, 166 days after the submission was received.
What is the product code of K863227?
The FDA product code is FHA – Clamp, Penile, a Class I (low risk) device regulated under 21 CFR 876.5160.