Vpi Non-Adhesive Condom Catheter
FDA 510(k) K883119 · Cook Urological, Inc.
510(k) numberK883119
Submission
- Device name
- Vpi Non-Adhesive Condom Catheter
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- July 25, 1988
- Decision date
- August 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYT – Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934080 | Urinary Drainage BagEYT · Traditional | Kit Pak, Inc. | 05/18/1994SE |
| K935774 | Curity Fast-Cath Female Catheter KitEYT · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 04/11/1994SEKD |
| K883057 | Comfort Cath Male External CatheterEYT · Traditional | Sierra Laboratories, Inc. | 08/02/1988SE |
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| 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 Vpi Non-Adhesive Condom Catheter cleared by the FDA?
Vpi Non-Adhesive Condom Catheter (K883119) received a 510(k) decision of Substantially Equivalent on August 2, 1988, 8 days after the submission was received.
What is the product code of K883119?
The FDA product code is EYT – Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.