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FDA 510(k)

OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE

K-Number: K982734 · 1998-10-05

ApplicantThe Olympus Optical Co.
Decision Date1998-10-05
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE is the device name listed in this FDA 510(k) record. The listed applicant is The Olympus Optical Co.. It received FDA 510(k) clearance on 1998-10-05 under 510(k) number K982734. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE?

OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE is a medical device that received FDA 510(k) clearance on 1998-10-05. The listed applicant is The Olympus Optical Co.. The 510(k) number is K982734.

When did OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE receive FDA 510(k) clearance?

OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE received FDA 510(k) clearance on 1998-10-05, under 510(k) number K982734.

Who is the listed applicant for OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE?

The FDA 510(k) record lists The Olympus Optical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE?

The FDA product code for OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE is ODG.

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Other records listing The Olympus Optical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032066SONOSURG SYSTEMK030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITK021962OLYMPUS ULTRASONIC SURGICAL SYSTEMK023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESK023272DISPOSABLE ASPIRATION NEEDLE NA-200HK023767UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES

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Related Devices (Code: ODG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK260428RIVOS™ EUS Access Device (M00553900)Boston Scientific CorporationK251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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