Cleared Traditional

K920224 - DOSCOPE AND ACESSORIES

K920224 is an FDA 510(k) clearance for DOSCOPE AND ACESSORIES, manufactured by Applied Laparoscopy. The device is a Class 2 Gastroenterology & Urology device with product code FBN cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K920224 · Applied Laparoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
217d
Days
Class 2
Risk

K920224 is an FDA 510(k) clearance for the DOSCOPE AND ACESSORIES. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by Applied Laparoscopy (Launa Hills, US). The FDA issued a Cleared decision on August 21, 1992 after a review of 217 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 Applied Laparoscopy devices

FDA 510(k) Submission Details - K920224

510(k) Number K920224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 17, 1992
Decision Date August 21, 1992
Days to Decision 217 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
87d slower than avg
Panel avg: 130d · This submission: 217d
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 K920224.
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