Cleared Traditional

K924228 - OMEGASCOPE

K924228 is an FDA 510(k) clearance for OMEGASCOPE, manufactured by Omega Universal Technologies, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FBN cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K924228 · Omega Universal Technologies, Ltd. · Gastroenterology & Urology device
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Feb 1993
Decision
189d
Days
Class 2
Risk

K924228 is an FDA 510(k) clearance for the OMEGASCOPE. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Omega Universal Technologies, Ltd. (Marlboro, US). The FDA issued a Cleared decision on February 26, 1993 after a review of 189 days - an extended review 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: 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 Omega Universal Technologies, Ltd. devices

FDA 510(k) Submission Details - K924228

510(k) Number K924228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1992
Decision Date February 26, 1993
Days to Decision 189 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 130d · This submission: 189d
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 K924228.
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
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
K912120 · Olympus Corp. · Aug 1991
FLEXIBLE CHOLEDOCHOSCOPE
K911480 · United States Endoscopy Group, Inc. · Jun 1991
CHF-B20 CHOLEDOCHOSCOPE
K904799 · Olympus Corp. · Mar 1991