510(k) K222980
K222980 is an FDA 510(k) premarket notification submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd. for the device "Pentax Medical Valve Set". The FDA issued a decision of Substantially Equivalent on November 21, 2022. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Yangzhou Fartley Medical Instrument Technology Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2022
- Date Received
- September 28, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To give the endoscope channel additional or improved functionality.