Cleared Traditional

K984255 - OLYMPUS HX-20 SERIES LIGATING DEVICE

K984255 is an FDA 510(k) clearance for OLYMPUS HX-20 SERIES LIGATING DEVICE, manufactured by Olympus Corp of America. The device is a Class 2 Gastroenterology & Urology device with product code MND cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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

FDA 510(k) Submission Details - K984255

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.

MND Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (MND) and FDA review panel - the closest regulatory comparables to K984255.
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · Olympus America, Inc. · Dec 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · Olympus America, Inc. · Feb 2001
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · Boston Scientific Corp · Jun 1999
HX-20/21-1 ENDOSCOPIC LIGATOR
K964661 · Olympus America, Inc. · Oct 1997
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
K971137 · C.R. Bard, Inc. · Oct 1997
WILSON COOK MULTIPLE BAND LIGATOR
K944220 · Wilson-Cook Medical, Inc. · Jan 1995