AUTOMATED ENDOSCOPE LEAK TESTER
FDA 510(k) clearance K123704 · decided 2013-02-04
Clearance details
- K-number
- K123704
- Device name
- AUTOMATED ENDOSCOPE LEAK TESTER
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-03
- Decision date
- 2013-02-04
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- PCV
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Center Valley, PA, 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 |
|---|---|---|
| PENTAX Medical Auto Leakage Tester SHA-P6 (K212201) | Pentax of America, Inc. | 2021-10-01 |
Recalls involving this device
No recalls on record reference this clearance.