Cleared Traditional

K834414 - ERCP CANNULA

K834414 is the FDA 510(k) clearance for ERCP CANNULA by Hobbs Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ODD) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K834414 · Hobbs Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
51d
Days
Class 2
Risk

K834414 is an FDA 510(k) clearance for the ERCP CANNULA. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Walker, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 51 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 Hobbs Medical, Inc. devices

Submission Details

510(k) Number K834414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1983
Decision Date February 04, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (ODD) and FDA review panel - the closest regulatory comparables to K834414.
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
K950700 · C.R. Bard, Inc. · Apr 1995
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
K950729 · Olympus America, Inc. · Mar 1995
DAVOL ERCP CANNULA
K845018 · C.R. Bard, Inc. · Jan 1985
E.R.C.P. CANNULA PRODUCT
K802443 · Mill-Rose Laboratory · Oct 1980