510(k) K210625
K210625 is an FDA 510(k) premarket notification submitted by Fujifilm Medwork GmbH for the device "JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve". The FDA issued a decision of Substantially Equivalent on Sep 10, 2021. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Fujifilm Medwork GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 10, 2021
- Date Received
- Mar 2, 2021
- 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
- 510(k)
To give the endoscope channel additional or improved functionality.