Cleared Traditional

K912120 - URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHO...

K912120 is the FDA 510(k) clearance for URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHO... by Olympus Corp.. It is a Class 2 Gastroenterology & Urology device (product code FBN) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K912120 · Olympus Corp. · Gastroenterology & Urology device
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Aug 1991
Decision
85d
Days
Class 2
Risk

K912120 is an FDA 510(k) clearance for the URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 85 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 Olympus Corp. devices

Submission Details

510(k) Number K912120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date August 07, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 130d · This submission: 85d
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 35
Devices cleared under the same product code (FBN) and FDA review panel - the closest regulatory comparables to K912120.
KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
K942112 · Karl Storz Endoscopy · Feb 1995
CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
K933906 · Fujinon, Inc. · Jul 1994
11274 AC FLEXINBLE CHOLEDOCHOSCOPE
K931382 · KARL STORZ Endoscopy-America, Inc. · Jun 1993
FLEXIBLE CHOLEDOCHOSCOPE
K911480 · United States Endoscopy Group, Inc. · Jun 1991
CHF-B20 CHOLEDOCHOSCOPE
K904799 · Olympus Corp. · Mar 1991
PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
K821974 · Pentax Precision Instrument Corp. · Aug 1982