URODEC 500
FDA 510(k) clearance K890284 · decided 1989-05-30
Clearance details
- K-number
- K890284
- Device name
- URODEC 500
- Applicant
- Ferguson Medical
- Decision
- Substantially Equivalent
- Date received
- 1989-01-19
- Decision date
- 1989-05-30
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- FES
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Chico, CA, 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 |
|---|---|---|
| MMI/GAELTEC CATHETER TIP PRESS. TRANSDU (K801757) | Medical Measurements, Inc. | 1980-08-27 |
Recalls involving this device
No recalls on record reference this clearance.