Catheter, Coude
The Coude Catheter (product code EZC) is a urinary catheter with a curved or angled tip designed to navigate around obstructions in the urethra, such as an enlarged prostate, during insertion into the bladder. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- EZC
- Device Class
- FDA class 2
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222279 | Rusch Intermittent Urethral Catheters | Aug 29, 2022 | Substantially Equivalent | Teleflex Medical |
| K173596 | Rusch Intermittent Urethral Catheters | Jan 29, 2018 | Substantially Equivalent | Teleflex Medical |
| K946282 | UNIVERSAL URETHRAL CATHETER | Mar 31, 1995 | Substantially Equivalent | Louisville Laboratories, Inc. |
| K913341 | BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER | Jan 27, 1992 | Substantially Equivalent | C.R. Bard, Inc. |
| K910846 | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | Aug 16, 1991 | Unknown | C.R. Bard, Inc. |
| K910197 | HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS | Aug 09, 1991 | Substantially Equivalent | C.R. Bard, Inc. |
| K910195 | BARD HYDROGEL-COATED FOLEY CATHETERS | Aug 09, 1991 | Substantially Equivalent | C.R. Bard, Inc. |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.