Cleared Traditional

K033954 - SHAPE LOCKING ENDOSCOPIC OVERTUBE

K033954 is an FDA 510(k) clearance for SHAPE LOCKING ENDOSCOPIC OVERTUBE, manufactured by Usgi Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K033954 · Usgi Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
88d
Days
Class 2
Risk

K033954 is an FDA 510(k) clearance for the SHAPE LOCKING ENDOSCOPIC OVERTUBE. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Usgi Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on March 19, 2004 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Usgi Medical, Inc. devices

FDA 510(k) Submission Details - K033954

510(k) Number K033954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date March 19, 2004
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K033954.
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
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · Boston Scientific Corp · May 2003