MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
FDA 510(k) clearance K801757 · decided 1980-08-27
Clearance details
- K-number
- K801757
- Device name
- MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
- Applicant
- Medical Measurements, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-28
- Decision date
- 1980-08-27
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- FES
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Measurements
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| URODEC 500 (K890284) | Ferguson Medical | 1989-05-30 |
Recalls involving this device
No recalls on record reference this clearance.