Cleared Special

K253568 - Hood DH-084STR (FDA 510(k) Clearance)

Also includes:
Hood DH-094STR Hood DH-104STR Hood DH-114STR Hood DH-124STR Hood DH-134STR

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253568 · Fujifilm Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
81d
Days
Class 2
Risk

K253568 is an FDA 510(k) clearance for the Hood DH-084STR. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on February 6, 2026 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fujifilm Corporation devices

Submission Details

510(k) Number K253568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date February 06, 2026
Days to Decision 81 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 130d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

FUJIFILM Healthcare Americas Corporation
Chaitrali Kulkarni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 74
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K253568.
EvoEndo Single-Use Endoscopy System
K260573 · EvoEndo, Inc. · Apr 2026
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K250550 · Fujifilm Corporation · Feb 2026
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · Pentax of America, Inc. · Dec 2025
GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
K251041 · Actuated Medical, Inc. · Oct 2025
EvoEndo Single-Use Endoscopy System
K251708 · EvoEndo, Inc. · Oct 2025
Disposable Distal Cap
K243388 · Micro-Tech (Nanjing) Co., Ltd. · Jun 2025