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FDA 510(k)

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

K-Number: K232314 · 2023-09-01

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2023-09-01
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-01 under approval number K232314. 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-106STL, DH-116STL, DH-126STL, DH-096ST)?

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K232314.

When was Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) approved by the FDA?

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) received FDA 510(k) clearance on 2023-09-01, under approval number K232314.

What company makes Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is manufactured by FUJIFILM Healthcare Americas Corporation.

What is the FDA product code for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?

The FDA product code for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is FDS.

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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.

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