Product code EZC— Gastroenterology, Urology
Rusch Intermittent Urethral Catheters
- Classification name
- Catheter, Coude
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code EZC
FDA has cleared devices under product code EZC between 1991 and 2022, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2018
- 1995
- 1992
- 1991
Top applicants under product code EZC
Adverse events under product code EZC
product code EZC- Injury
- 772
- Malfunction
- 6,262
- Other
- 1
- Total
- 7,035
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code EZC
- K222279 — Rusch Intermittent Urethral Catheters
- K173596 — Rusch Intermittent Urethral Catheters
- K946282 — UNIVERSAL URETHRAL CATHETER
- K913341 — BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
- K910846 — BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF
- K910195 — BARD HYDROGEL-COATED FOLEY CATHETERS
- K910197 — HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
Data sourced from openFDA. This site is unofficial and independent of the FDA.