Cleared Traditional

K910769 - SURGITEK ERCP CONTRAST MEDIA SYSTEM

K910769 is an FDA 510(k) clearance for SURGITEK ERCP CONTRAST MEDIA SYSTEM, manufactured by Surgitek Medical Engineering Corp.. The device is a Class 2 Gastroenterology & Urology device with product code ODD cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K910769 · Surgitek Medical Engineering Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
123d
Days
Class 2
Risk

K910769 is an FDA 510(k) clearance for the SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by Surgitek Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on June 25, 1991 after a review of 123 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.

View all Surgitek Medical Engineering Corp. devices

FDA 510(k) Submission Details - K910769

510(k) Number K910769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1991
Decision Date June 25, 1991
Days to Decision 123 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
7d faster than avg
Panel avg: 130d · This submission: 123d
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 11
Devices cleared under the same product code (ODD) and FDA review panel - the closest regulatory comparables to K910769.
ERCP CANNULA
K963051 · United States Endoscopy Group, Inc. · Mar 1997
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