Cleared Traditional

K161147 - EndoCure Model EUR078A

K161147 is an FDA 510(k) clearance for EndoCure Model EUR078A, manufactured by Endocure Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBN cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K161147 · Endocure Technologies, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2016
Decision
46d
Days
Class 2
Risk

K161147 is an FDA 510(k) clearance for the EndoCure Model EUR078A. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Endocure Technologies, Inc. (Beltsville, US). The FDA issued a Cleared decision on June 7, 2016 after a review of 46 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 Endocure Technologies, Inc. devices

FDA 510(k) Submission Details - K161147

510(k) Number K161147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2016
Decision Date June 07, 2016
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
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.

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All 36
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