COMFORT CATH MALE EXTERNAL CATHETER
FDA 510(k) clearance K883057 · decided 1988-08-02
Clearance details
- K-number
- K883057
- Device name
- COMFORT CATH MALE EXTERNAL CATHETER
- Applicant
- Sierra Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-19
- Decision date
- 1988-08-02
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- EYT
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tucson, AZ, 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 |
|---|---|---|
| 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 |
| VPI NON-ADHESIVE CONDOM CATHETER (K883119) | Cook Urological, Inc. | 1988-08-02 |
Recalls involving this device
No recalls on record reference this clearance.