Cleared Traditional

K982734 - OLYMPUS MH-246R BALLOON SHEATH

K982734 is an FDA 510(k) clearance for OLYMPUS MH-246R BALLOON SHEATH, manufactured by The Olympus Optical Co.. The device is a Class 2 Radiology device with product code ODG cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K982734 · The Olympus Optical Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
61d
Days
Class 2
Risk

K982734 is an FDA 510(k) clearance for the OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on October 5, 1998 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.1500 - the FDA radiology and imaging software oversight 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 The Olympus Optical Co. devices

FDA 510(k) Submission Details - K982734

510(k) Number K982734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1998
Decision Date October 05, 1998
Days to Decision 61 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 107d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODG Device Classification - Class 2, Special Controls

Product Code ODG Endoscopic Ultrasound System, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. 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 Radiology devices follow this clearance model.

Regulatory Peers - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 37
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K982734.
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · Pentax Precision Instrument Corp. · Sep 2002
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
K011886 · Olympus America, Inc. · Aug 2001
FG-36UX, FIBER ULTRASOUND GASTROSCOPE
K010740 · Pentax Precision Instrument Corp. · Apr 2001
OLYMPUS MH-246R BALLOON SHEATH
K961048 · Olympus America, Inc. · Sep 1996
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
K953876 · Pentax Precision Instrument Corp. · Nov 1995
ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20
K926514 · Olympus Corp. · Aug 1993