FDA 510(k)

Hood (DH-083ST)

K-Number: K242779 · 2024-10-11

Decision Date2024-10-11

Product CodeFDS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Hood (DH-083ST) is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2024-10-11 under approval number K242779. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hood (DH-083ST)?

Hood (DH-083ST) is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by Fujifilm Corporation. The 510(k) number is K242779.

When was Hood (DH-083ST) approved by the FDA?

Hood (DH-083ST) received FDA 510(k) clearance on 2024-10-11, under approval number K242779.

What company makes Hood (DH-083ST)?

Hood (DH-083ST) is manufactured by Fujifilm Corporation.

What is the FDA product code for Hood (DH-083ST)?

The FDA product code for Hood (DH-083ST) is FDS.

Other Devices by Fujifilm Corporation

K182051FUJIFILM Duodenoscope Model K181773Synapse 3D Optional Tools K180341FUJIFILM 600 Series Endoscope EG-600WR v2 K181763FUJIFILM Ultrasonic Endoscope K180711FUJIFILM Endoscopic CO2 Regulator GW-100 K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS

View all 62 devices →

Related Devices (Code: FDS)

K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc. K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation K180911Visura Technologies TEECAD SystemVisura Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.