Cleared Traditional

K123013 - ENDOSCOPIC INTRODUCER

K123013 is an FDA 510(k) clearance for ENDOSCOPIC INTRODUCER, manufactured by Novadaq Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K123013 · Novadaq Technologies, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2013
Decision
175d
Days
Class 2
Risk

K123013 is an FDA 510(k) clearance for the ENDOSCOPIC INTRODUCER. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Novadaq Technologies, Inc. (Richmond British Columbia, CA). The FDA issued a Cleared decision on March 22, 2013 after a review of 175 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 Novadaq Technologies, Inc. devices

FDA 510(k) Submission Details - K123013

510(k) Number K123013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date March 22, 2013
Days to Decision 175 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
45d slower than avg
Panel avg: 130d · This submission: 175d
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 K123013.
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
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ANAL RECTAL OVERTUBE
K131598 · United States Endoscopy Group, Inc. · Feb 2014
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
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · Boston Scientific Corp · Dec 2012
RE-TRACE URETERAL ACCESS SHEATH
K102485 · Coloplast A/S · Oct 2010