510(k) K212201
K212201 is an FDA 510(k) premarket notification submitted by Pentax of America, Inc. for the device "PENTAX Medical Auto Leakage Tester SHA-P6". The FDA issued a decision of Substantially Equivalent on October 1, 2021. The device falls under product code PCV (Endoscopic Leak Tester), a Class II device regulated under 21 CFR 876.1500. Pentax of America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2021
- Date Received
- July 14, 2021
- 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.