Cleared Traditional

FLEXIBLE CHOLEDOCHOSCOPE (K901010) - FDA 510(k) Clearance

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

K901010 · Intramed Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
78d
Days
Class 2
Risk

K901010 is an FDA 510(k) clearance for the FLEXIBLE CHOLEDOCHOSCOPE. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 22, 1990 after a review of 78 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 Intramed Laboratories, Inc. devices

Submission Details

510(k) Number K901010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date May 22, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
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 24
Devices cleared under the same product code (FBN) and FDA review panel - the closest regulatory comparables to K901010.
11274 AC FLEXINBLE CHOLEDOCHOSCOPE
K931382 · KARL STORZ Endoscopy-America, Inc. · Jun 1993
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
K912120 · Olympus Corp. · Aug 1991
CHF-B20 CHOLEDOCHOSCOPE
K904799 · Olympus Corp. · Mar 1991
CHOLEDOCHOSCOPE SYSTEM
K771367 · Richard Wolf Medical Instruments Corp. · Aug 1977