Catheter, Retention Type
The Retention-Type Catheter (product code EZK) is a urinary catheter designed to remain in place within the bladder for continuous drainage, typically secured by a mechanism that prevents displacement. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. It is regulated under 21 CFR 876.5980 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- EZK
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911349 | E-Z-EM ENTEROCLYSIS CATHETER SET | Nov 16, 1992 | Substantially Equivalent | E-Z-Em, Inc. |
| K903816 | URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR | Oct 31, 1990 | Unknown | Respiratory Support Products, Inc. |
| K770408 | KARAYA GUM POWDER, OSTOMY | Mar 15, 1977 | Substantially Equivalent | Howmedica Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.