Cleared Traditional

K051886 - OLYMPUS CHOLEDOCHOSCOPE

K051886 is the FDA 510(k) clearance for OLYMPUS CHOLEDOCHOSCOPE by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FBN) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K051886 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Nov 2005
Decision
125d
Days
Class 2
Risk

K051886 is an FDA 510(k) clearance for the OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on November 14, 2005 after a review of 125 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K051886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2005
Decision Date November 14, 2005
Days to Decision 125 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 130d · This submission: 125d
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 34
Devices cleared under the same product code (FBN) and FDA review panel - the closest regulatory comparables to K051886.
OLYMPUS CHF TYPE V
K081456 · Olympus Medical Systems Corporation · Nov 2008
XCHF-T160 VIDEOSCOPE
K082576 · Olympus Medical Systems Corporation · Oct 2008
OLYMPUS XCHF TYPE B180Y1
K080586 · Olympus Medical Systems Corporation · May 2008
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
FLEXIBLE MINI-FIBERSCOPES
K962172 · Richard Wolf Medical Instruments Corp. · Dec 1996