Cleared Traditional

K913294 - SURGITEK LAPAROSCOPIC CHOLANGIOGRAM KIT

K913294 is an FDA 510(k) clearance for SURGITEK LAPAROSCOPIC CHOLANGIOGRAM KIT, manufactured by Surgitek Medical Engineering Corp.. The device is a Class 2 Gastroenterology & Urology device with product code GCA cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K913294 · Surgitek Medical Engineering Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 1991
Decision
72d
Days
Class 2
Risk

K913294 is an FDA 510(k) clearance for the SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT. Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by Surgitek Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Surgitek Medical Engineering Corp. devices

FDA 510(k) Submission Details - K913294

510(k) Number K913294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1991
Decision Date October 04, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCA Device Classification - Class 2, Special Controls

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 20
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K913294.
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K915343 · Uresil Corp. · Mar 1992
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · Davol, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT
K915506 · United States Endoscopy Group, Inc. · Mar 1992
LAPAROSCOPIC CHOLANGIOCATH
K911487 · United States Endoscopy Group, Inc. · Aug 1991
T-TUBE WHELAN-MOSS
K772292 · Davol, Inc. · Dec 1977