# K221264: FROG Forceps Valve (VAL1-F1-100)

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medwork GmbH
- Decided: Jun 1, 2022 after 30 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001241 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210625: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve, Fujifilm Medwork GmbH (2021) Summary page 4.

## Indications for use
The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or back flow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.

Source page: https://510kreport.com/device/K221264
Methodology: https://510kreport.com/methodology