Cleared Special

K243091 - Over-tube (TR-1108A)

K243091 is an FDA 510(k) clearance for Over-tube (TR-1108A), manufactured by Fujifilm Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Special 510(k) pathway after a 32-day FDA review.

K243091 · Fujifilm Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
32d
Days
Class 2
Risk

K243091 is an FDA 510(k) clearance for the Over-tube (TR-1108A). Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on November 1, 2024 after a review of 32 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 - K243091

510(k) Number K243091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date November 01, 2024
Days to Decision 32 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
99d faster than avg
Panel avg: 131d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 103
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K243091.
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K240853 · Neptune Medical, Inc. · Jun 2024
K243091 · Over-tube (TR-1108A)
Download PDF FDA Summary Fujifilm Corporation