Cleared Traditional

FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE (K951191) - FDA 510(k) Clearance

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

K951191 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
75d
Days
Class 2
Risk

K951191 is an FDA 510(k) clearance for the FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 75 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K951191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1995
Decision Date May 30, 1995
Days to Decision 75 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
55d faster than avg
Panel avg: 130d · This submission: 75d
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 K951191.
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