VPI NON-ADHESIVE CONDOM CATHETER
FDA 510(k) clearance K883119 · decided 1988-08-02
Clearance details
- K-number
- K883119
- Device name
- VPI NON-ADHESIVE CONDOM CATHETER
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-25
- Decision date
- 1988-08-02
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- EYT
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cook Urological
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| URINARY DRAINAGE BAG (K934080) | Kit Pak, Inc. | 1994-05-18 |
| CURITY FAST-CATH FEMALE CATHETER KIT (K935774) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-04-11 |
| COMFORT CATH MALE EXTERNAL CATHETER (K883057) | Sierra Laboratories, Inc. | 1988-08-02 |
Recalls involving this device
No recalls on record reference this clearance.