Cleared Special

K183683 - FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

K183683 is an FDA 510(k) clearance for FUJIFILM Double Balloon Endoscopes EN-580T, manufactured by Fujifilm Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FDA cleared through the Special 510(k) pathway after a 61-day FDA review.

K183683 · Fujifilm Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
61d
Days
Class 2
Risk

K183683 is an FDA 510(k) clearance for the FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on February 27, 2019 after a review of 61 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.

FDA 510(k) Submission Details - K183683

510(k) Number K183683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2018
Decision Date February 27, 2019
Days to Decision 61 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
70d faster than avg
Panel avg: 131d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

FDA Device Classification - Class 2, Special Controls

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 Consultant

Fujifilm Medical Systems U.S.A, Inc.
Jeffrey Wan

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 - FDA Enteroscope And Accessories

All 19
Devices cleared under the same product code (FDA) and FDA review panel - the closest regulatory comparables to K183683.
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Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2015
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K071254 · Olympus Medical Systems Corporation · Mar 2008
NAVIAID BGE DEVICE, MODEL 21-001
K060923 · Smart Medical Systems , Ltd. · Aug 2006
K183683 · FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
Download PDF FDA Summary Fujifilm Corporation