Cleared Traditional

K953967 - ENDOSCOPIC CATHETER

K953967 is an FDA 510(k) clearance for ENDOSCOPIC CATHETER, manufactured by Act Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ODD cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K953967 · Act Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
153d
Days
Class 2
Risk

K953967 is an FDA 510(k) clearance for the ENDOSCOPIC CATHETER. Classified as Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (product code ODD), Class II - Special Controls.

Submitted by Act Medical, Inc. (Waltham, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 153 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 Act Medical, Inc. devices

FDA 510(k) Submission Details - K953967

510(k) Number K953967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date January 22, 1996
Days to Decision 153 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
23d slower than avg
Panel avg: 130d · This submission: 153d
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 K953967.
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · Boston Scientific Corp · Apr 2001
WILSON-COOK STRICTURE MEASURING CATHETER
K973205 · Wilson-Cook Medical, Inc. · Nov 1997
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