Rusch Intermittent Urethral Catheters
FDA 510(k) clearance K222279 · decided 2022-08-29
Clearance details
- K-number
- K222279
- Device name
- Rusch Intermittent Urethral Catheters
- Applicant
- Teleflex Medical
- Decision
- Substantially Equivalent
- Date received
- 2022-07-29
- Decision date
- 2022-08-29
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- EZC
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Morrisville, NC, 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 (K173596) | Teleflex Medical | 2018-01-29 |
| UNIVERSAL URETHRAL CATHETER (K946282) | Louisville Laboratories, Inc. | 1995-03-31 |
| 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.