UNIVERSAL URETHRAL CATHETER
FDA 510(k) clearance K946282 · decided 1995-03-31
Clearance details
- K-number
- K946282
- Device name
- UNIVERSAL URETHRAL CATHETER
- Applicant
- Louisville Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-27
- Decision date
- 1995-03-31
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- EZC
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Louisville, KY, 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 |
|---|---|---|
| Rusch Intermittent Urethral Catheters (K222279) | Teleflex Medical | 2022-08-29 |
| Rusch Intermittent Urethral Catheters (K173596) | Teleflex Medical | 2018-01-29 |
| BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER (K913341) | C.R. Bard, Inc. | 1992-01-27 |
| BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF (K910846) | C.R. Bard, Inc. | 1991-08-16 |
| HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS (K910197) | C.R. Bard, Inc. | 1991-08-09 |
| BARD HYDROGEL-COATED FOLEY CATHETERS (K910195) | C.R. Bard, Inc. | 1991-08-09 |
Recalls involving this device
No recalls on record reference this clearance.