Cleared Traditional

K122649 - NAVIGATOR HD URETERAL ACCESS SHEATH SET

K122649 is an FDA 510(k) clearance for NAVIGATOR HD URETERAL ACCESS SHEATH SET, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K122649 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
104d
Days
Class 2
Risk

K122649 is an FDA 510(k) clearance for the NAVIGATOR HD URETERAL ACCESS SHEATH SET. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on December 12, 2012 after a review of 104 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K122649

510(k) Number K122649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2012
Decision Date December 12, 2012
Days to Decision 104 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 131d · This submission: 104d
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 101
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K122649.
ENDORINGS
K133359 · Endo-Aid, Inc. · Feb 2014
ENDOSCOPIC INTRODUCER
K123013 · Novadaq Technologies, Inc. · Mar 2013
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
K123675 · Coloplast A/S · Mar 2013
OVERTUBE ENDOSCOPIC ACCESS SYSTEM
K122270 · Apollo Endosurgery, Inc. · Sep 2012
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
K120126 · Barosense, Inc. · Sep 2012
ARC ENDOCUFF
K122565 · Boddingtons Plastics, Ltd. · Sep 2012
K122649 · NAVIGATOR HD URETERAL ACCESS SHEATH SET
Download PDF FDA Summary Boston Scientific Corp