Cleared Special

K030956 - NAVIGATOR URETERAL ACCESS SHEATH SET

K030956 is the FDA 510(k) clearance for NAVIGATOR URETERAL ACCESS SHEATH SET by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Special 510(k) pathway after a 57-day FDA review.

K030956 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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May 2003
Decision
57d
Days
Class 2
Risk

K030956 is an FDA 510(k) clearance for the NAVIGATOR URETERAL ACCESS SHEATH SET. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 57 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 Boston Scientific Corp devices

Submission Details

510(k) Number K030956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2003
Decision Date May 23, 2003
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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 62
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K030956.
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
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · C.R. Bard, Inc. · Mar 2003
URETERAL ACCESS SHEATH SET - NEW MODELS
K993650 · Applied Medical Resources · Dec 1999
URETERAL ACCESS SHEATH SET
K990775 · Applied Medical Resources · Apr 1999