Cleared Traditional

Over-tube (TR-1208A) (K230752) - FDA 510(k) Clearance

Also marketed or referenced as:
Over-tube (TR-1504A) Over-tube (TR-1507A)

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

K230752 · Fujifilm Healthcare Americas Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
182d
Days
Class 2
Risk

K230752 is an FDA 510(k) clearance for the Over-tube (TR-1208A). Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on September 15, 2023 after a review of 182 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 Healthcare Americas Corporation devices

Submission Details

510(k) Number K230752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2023
Decision Date September 15, 2023
Days to Decision 182 days
Submission Type Traditional
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
52d slower than avg
Panel avg: 130d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 48
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K230752.
Disposable Ureteral Guide Sheath
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Pathfinder® CR System
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K233472 · Calyxo, Inc. · Feb 2024
Disposable Ureteral Access Sheath
K230748 · Youcare Technology Co.,Ltd. (Wuhan) · Aug 2023
Pathfinder Endoscope Overtube with Balloon Device
K230801 · Neptune Medical, Inc. · Jul 2023
Single Use Ureteral Access Sheath
K220065 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · May 2022