Cleared Special

K091773 - FUJINON STERILE OVERTUBES

K091773 is an FDA 510(k) clearance for FUJINON STERILE OVERTUBES, manufactured by Fujinon, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Special 510(k) pathway after a 52-day FDA review.

K091773 · Fujinon, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
52d
Days
Class 2
Risk

K091773 is an FDA 510(k) clearance for the FUJINON STERILE OVERTUBES. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Fujinon, Inc. (Shelton, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 52 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 - K091773

510(k) Number K091773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date August 07, 2009
Days to Decision 52 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
79d faster than avg
Panel avg: 131d · This submission: 52d
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 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 K091773.
ENTEROSCOPY OVERTUBE, MODEL 00712140
K100081 · United States Endoscopy Group, Inc. · Apr 2010
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K092221 · United States Endoscopy Group, Inc. · Oct 2009
CAD 12, COLONOSCOPY ASSIST DEVICE
K092156 · Softscope Medical Technologies, Inc. · Oct 2009
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
K082589 · Barosense, Inc. · May 2009
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
K080050 · Spirus Medical, Inc. · May 2008
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
K072405 · Usgi Medical · Sep 2007
K091773 · FUJINON STERILE OVERTUBES
Download PDF FDA Summary Fujinon, Inc.