E-Z-EM ENTEROCLYSIS CATHETER SET
FDA 510(k) clearance K911349 · decided 1992-11-16
Clearance details
- K-number
- K911349
- Device name
- E-Z-EM ENTEROCLYSIS CATHETER SET
- Applicant
- E-Z-Em, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-27
- Decision date
- 1992-11-16
- Days to decision
- 600 days
- Clearance type
- Traditional
- Product code
- EZK
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Westbury, NY, 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 |
|---|---|---|
| URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (K903816) | Respiratory Support Products, Inc. | 1990-10-31 |
| KARAYA GUM POWDER, OSTOMY (K770408) | Howmedica Corp. | 1977-03-15 |
Recalls involving this device
No recalls on record reference this clearance.