Cleared Special

K050253 - USGI SHAPELOCK ENDOSCOPIC GUIDE

K050253 is an FDA 510(k) clearance for USGI SHAPELOCK ENDOSCOPIC GUIDE, manufactured by Usgi Medical. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Special 510(k) pathway after a 25-day FDA review.

K050253 · Usgi Medical · Gastroenterology & Urology device
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Feb 2005
Decision
25d
Days
Class 2
Risk

K050253 is an FDA 510(k) clearance for the USGI SHAPELOCK ENDOSCOPIC GUIDE. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Usgi Medical (San Clemente, US). The FDA issued a Cleared decision on February 28, 2005 after a review of 25 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.

View all Usgi Medical devices

FDA 510(k) Submission Details - K050253

510(k) Number K050253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2005
Decision Date February 28, 2005
Days to Decision 25 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
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 67
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K050253.
FUJINON STERILE OVERTUBES
K091773 · Fujinon, Inc. · Aug 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · Boston Scientific Corp · Jun 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · Cook Urological, Inc. · Mar 2005
DISPOSABLE OVERTUBE
K040836 · United States Endoscopy Group, Inc. · Jun 2004
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
K033778 · C.R. Bard, Inc. · Dec 2003
DEFLECTING URETERAL ACCESS SHEATH
K030642 · Applied Medical Resources Corp. · May 2003