510(k) K123704
K123704 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "AUTOMATED ENDOSCOPE LEAK TESTER". The FDA issued a decision of Substantially Equivalent on February 4, 2013. The device falls under product code PCV (Endoscopic Leak Tester), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2013
- Date Received
- December 3, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Leak Tester
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope.