Cleared Traditional

OLYMPUS PBD STENTS (K933200) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933200 · Olympus Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
643d
Days
Class 2
Risk

K933200 is an FDA 510(k) clearance for the OLYMPUS PBD STENTS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 643 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Olympus Corp. devices

Submission Details

510(k) Number K933200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date April 05, 1995
Days to Decision 643 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
513d slower than avg
Panel avg: 130d · This submission: 643d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 187
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K933200.
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
K962925 · Olympus America, Inc. · Oct 1996
CORDIS BILIARY STENT
K955728 · Cordis Corp. · May 1996
OLYMPUS NBD TUBES
K944912 · Olympus America, Inc. · Jun 1995
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994
ELIMINATOR BALLOON DILATOR
K940965 · C.R. Bard, Inc. · May 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994