Cleared Traditional

K143556 - Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143556 · Fujifilm Medical Systems U.S.A, Inc. · Gastroenterology & Urology device
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Aug 2015
Decision
248d
Days
Class 2
Risk

K143556 is an FDA 510(k) clearance for the Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on August 20, 2015 after a review of 248 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Medical Systems U.S.A, Inc. devices

Submission Details

510(k) Number K143556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date August 20, 2015
Days to Decision 248 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 130d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K143556.
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K251204 · Fujifilm Healthcare Americas Corporation · Sep 2025
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K233321 · Fujifilm Healthcare Americas Corporation · Jun 2024
Ancora-SB
K231323 · Aspero Medical, Inc. · Aug 2023
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
K223295 · Fujifilm Corporaton · Jan 2023
Balloon BS-3
K213195 · Fujifilm Corporation · Oct 2021