Cleared Traditional

OLYMPUS HX-20 SERIES LIGATING DEVICE (K984255) - FDA 510(k) Clearance

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

K984255 · Olympus Corp of America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
43d
Days
Class 2
Risk

K984255 is an FDA 510(k) clearance for the OLYMPUS HX-20 SERIES LIGATING DEVICE. Classified as Ligator, Esophageal (product code MND), Class II - Special Controls.

Submitted by Olympus Corp of America (Lake Success, US). The FDA issued a Cleared decision on January 12, 1999 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - 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 Olympus Corp of America devices

Submission Details

510(k) Number K984255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1998
Decision Date January 12, 1999
Days to Decision 43 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 faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MND Ligator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
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 - MND Ligator, Esophageal

All 14
Devices cleared under the same product code (MND) and FDA review panel - the closest regulatory comparables to K984255.
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · C.R. Bard, Inc. · Nov 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · C.R. Bard, Inc. · Aug 2002
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · Boston Scientific Corp · Jun 1999
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
K971137 · C.R. Bard, Inc. · Oct 1997
STIEGMANN-GOFF ENDOSCOPIC LIGATOR
K940661 · C.R. Bard, Inc. · Nov 1994