ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
FDA 510(k) clearance K093718 · decided 2010-02-22
Clearance details
- K-number
- K093718
- Device name
- ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
- Applicant
- Zutron Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-12-02
- Decision date
- 2010-02-22
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- FCY
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lenexa, KS, 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 |
|---|---|---|
| ANEROID BLOOD PRESSURE GAUGE (K904376) | Biomedical Dynamics, Inc. | 1990-12-20 |
| TRANS/R - FP(3) (K900016) | CIVCO Medical Instruments Co., Inc. | 1990-06-11 |
Recalls involving this device
No recalls on record reference this clearance.