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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 the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-01 under 510(k) 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. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K232314.

When did Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) receive FDA 510(k) clearance?

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

Who is the listed applicant for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing FUJIFILM Healthcare Americas Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261713Synapse PACS (7.6.0)K251204FUJIFILM Stiffening Wire Device (SW-2000)K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CK233629APERTO Lucent MRI SystemK233687ECHELON Synergy V10.0

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Related Devices (Code: FDS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.

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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