Cleared Special

K223295 - Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (FDA 510(k) Clearance)

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

K223295 · Fujifilm Corporaton · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
77d
Days
Class 2
Risk

K223295 is an FDA 510(k) clearance for the Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Fujifilm Corporaton (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on January 11, 2023 after a review of 77 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 Corporaton devices

Submission Details

510(k) Number K223295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2022
Decision Date January 11, 2023
Days to Decision 77 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FDA Enteroscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Visualization And Perform Various Procedures Within The Small Intestine. 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 Peers - FDA Enteroscope And Accessories

All 19
Devices cleared under the same product code (FDA) and FDA review panel - the closest regulatory comparables to K223295.
Ancora-SB
K260314 · Aspero Medical, Inc. · May 2026
FUJIFILM Stiffening Wire Device (SW-2000)
K251204 · Fujifilm Healthcare Americas Corporation · Sep 2025
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · Fujifilm Healthcare Americas Corporation · Jun 2024
Ancora-SB
K231323 · Aspero Medical, Inc. · Aug 2023
Balloon BS-3
K213195 · Fujifilm Corporation · Oct 2021