URINARY DRAINAGE BAG
FDA 510(k) clearance K934080 · decided 1994-05-18
Clearance details
- K-number
- K934080
- Device name
- URINARY DRAINAGE BAG
- Applicant
- Kit Pak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-20
- Decision date
- 1994-05-18
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- EYT
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elk Grove Village, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| VPI NON-ADHESIVE CONDOM CATHETER (K883119) | Cook Urological, Inc. | 1988-08-02 |
Recalls involving this device
No recalls on record reference this clearance.