Cleared Traditional

K060235 - ENDO-EASE ENDOSCOPIC OVERTUBE

K060235 is an FDA 510(k) clearance for ENDO-EASE ENDOSCOPIC OVERTUBE, manufactured by Spirus Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDA cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K060235 · Spirus Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
186d
Days
Class 2
Risk

K060235 is an FDA 510(k) clearance for the ENDO-EASE ENDOSCOPIC OVERTUBE. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Spirus Medical, Inc. (Ayer, US). The FDA issued a Cleared decision on August 4, 2006 after a review of 186 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 Spirus Medical, Inc. devices

FDA 510(k) Submission Details - K060235

510(k) Number K060235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2006
Decision Date August 04, 2006
Days to Decision 186 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
56d slower than avg
Panel avg: 130d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FDA Enteroscope And Accessories

All 15
Devices cleared under the same product code (FDA) and FDA review panel - the closest regulatory comparables to K060235.
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
K183683 · Fujifilm Corporation · Feb 2019
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
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
K040048 · Fujinon, Inc. · Jun 2004
GASTRO-INTESTINAL SYSTEM EN-410WM
K993704 · Fujinon, Inc. · Feb 2000
SIF-SW
K904800 · Olympus Corp. · Mar 1991