Cleared Traditional

K833417 - ENDOSCOPIC RETROGRADE

K833417 is an FDA 510(k) clearance for ENDOSCOPIC RETROGRADE, manufactured by Microvasive. The device is a Class 2 Gastroenterology & Urology device with product code ODD cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K833417 · Microvasive · Gastroenterology & Urology device
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Nov 1983
Decision
56d
Days
Class 2
Risk

K833417 is an FDA 510(k) clearance for the ENDOSCOPIC RETROGRADE. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by Microvasive (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 56 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 Microvasive devices

FDA 510(k) Submission Details - K833417

510(k) Number K833417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1983
Decision Date November 28, 1983
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 131d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODD Device Classification - Class 2, Special Controls

Product Code ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.
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 - ODD Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

All 15
Devices cleared under the same product code (ODD) and FDA review panel - the closest regulatory comparables to K833417.
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
K950729 · Olympus America, Inc. · Mar 1995
DAVOL ERCP CANNULA
K845018 · C.R. Bard, Inc. · Jan 1985
ERCP CANNULA
K834414 · Hobbs Medical, Inc. · Feb 1984
E.R.C.P. CANNULAS
K820431 · American Endoscopy, Inc. · Apr 1982
E.R.C.P. CANNULA PRODUCT
K802443 · Mill-Rose Laboratory · Oct 1980