Cleared Traditional

K141991 - SINGLE USE PRELOADED SPHINCTEROTOME V (...

Also marketed or referenced as:
SINGLE USE SP

K141991 is an FDA 510(k) clearance for SINGLE USE PRELOADED SPHINCTEROTOME V (..., manufactured by Olympus Medical Systems Copr.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K141991 · Olympus Medical Systems Copr. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
252d
Days
Class 2
Risk

K141991 is an FDA 510(k) clearance for the SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED). Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Olympus Medical Systems Copr. (Center Valley, US). The FDA issued a Cleared decision on March 31, 2015 after a review of 252 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Olympus Medical Systems Copr. devices

FDA 510(k) Submission Details - K141991

510(k) Number K141991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2014
Decision Date March 31, 2015
Days to Decision 252 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
122d slower than avg
Panel avg: 130d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K141991.
Single Use Electrosurgical knife
K171158 · Olympus Medical Systems Corp. · Nov 2017
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
K160241 · Olympus Medical Systems Corp. · Mar 2016
Single Use Balloon Dilator V (with Knife)
K150142 · Olympus Medical Systems Corp. · Oct 2015
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · Boston Scientific Corporation · Apr 2014
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
K130623 · Covidien, LLC · Jul 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
K122505 · Olympus Medical Systems Corp. · Apr 2013