Cleared Traditional

KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE (K942112) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942112 · Karl Storz Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
302d
Days
Class 2
Risk

K942112 is an FDA 510(k) clearance for the KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on February 28, 1995 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Karl Storz Endoscopy devices

Submission Details

510(k) Number K942112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1994
Decision Date February 28, 1995
Days to Decision 302 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
172d slower than avg
Panel avg: 130d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBN Choledochoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Bile Ducts. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FBN Choledochoscope And Accessories, Flexible/rigid

All 19
Devices cleared under the same product code (FBN) and FDA review panel - the closest regulatory comparables to K942112.
SpyGlass DS Direct Visualization System
K142922 · Boston Scientific Corporation · Jan 2015
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
K972926 · KARL STORZ Endoscopy-America, Inc. · Oct 1997
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
K971977 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
11274 AC FLEXINBLE CHOLEDOCHOSCOPE
K931382 · KARL STORZ Endoscopy-America, Inc. · Jun 1993