Cleared Traditional

K060269 - ACMI DUR-DIGITAL URETEROSCOPE AND CHOLE...

K060269 is an FDA 510(k) clearance for ACMI DUR-DIGITAL URETEROSCOPE AND CHOLE..., manufactured by Acmi Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FBN cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K060269 · Acmi Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
58d
Days
Class 2
Risk

K060269 is an FDA 510(k) clearance for the ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on March 31, 2006 after a review of 58 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 Acmi Corporation devices

FDA 510(k) Submission Details - K060269

510(k) Number K060269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2006
Decision Date March 31, 2006
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBN Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (FBN) and FDA review panel - the closest regulatory comparables to K060269.
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