510(k) K221264
K221264 is an FDA 510(k) premarket notification submitted by Fujifilm Medwork GmbH for the device "FROG Forceps Valve (VAL1-F1-100)". The FDA issued a decision of Substantially Equivalent on Jun 1, 2022. 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
- Jun 1, 2022
- Date Received
- May 2, 2022
- Clearance Type
- Special
- 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.