meddevicedb.com FDA Device Reference

FROG Forceps Valve (VAL1-F1-100)

K221264 Class II Special
Decision Date
2022-06-01
Sponsor / Applicant
Fujifilm Medwork GmbH

Technical Specification

510(k) Submission ID K221264
Product Code ODC
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1500
Decision Date 2022-06-01
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

FROG Forceps Valve (VAL1-F1-100) received FDA 510(k) clearance under submission number K221264, sponsored by Fujifilm Medwork GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2022-06-01.

Classification & Regulation

This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.