Cleared Traditional

K942338 - OLYMPUS PF-8P OES PANCREATO FIBERSCOPE ...

K942338 is an FDA 510(k) clearance for OLYMPUS PF-8P OES PANCREATO FIBERSCOPE ..., manufactured by Olympus Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FDT cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K942338 · Olympus Corp. · Gastroenterology & Urology device
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Nov 1994
Decision
198d
Days
Class 2
Risk

K942338 is an FDA 510(k) clearance for the OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES. Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on November 30, 1994 after a review of 198 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 Olympus Corp. devices

FDA 510(k) Submission Details - K942338

510(k) Number K942338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1994
Decision Date November 30, 1994
Days to Decision 198 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 130d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDT Device Classification - Class 2, Special Controls

Product Code FDT Duodenoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type 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 - FDT Duodenoscope And Accessories, Flexible/rigid

All 31
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K942338.
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