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FDA 510(k)

OLYMPUS BF TYPE UC160-OL8

K-Number: K042140 · 2004-08-18

ApplicantOlympus Corporation
Decision Date2004-08-18
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS BF TYPE UC160-OL8 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corporation. It received FDA 510(k) clearance on 2004-08-18 under 510(k) number K042140. 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 BF TYPE UC160-OL8?

OLYMPUS BF TYPE UC160-OL8 is a medical device that received FDA 510(k) clearance on 2004-08-18. The listed applicant is Olympus Corporation. The 510(k) number is K042140.

When did OLYMPUS BF TYPE UC160-OL8 receive FDA 510(k) clearance?

OLYMPUS BF TYPE UC160-OL8 received FDA 510(k) clearance on 2004-08-18, under 510(k) number K042140.

Who is the listed applicant for OLYMPUS BF TYPE UC160-OL8?

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

What is the FDA product code for OLYMPUS BF TYPE UC160-OL8?

The FDA product code for OLYMPUS BF TYPE UC160-OL8 is ODG.

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Other records listing Olympus Corporation 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.

K072643CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/USK043128OLYMPUS ENDOARMK041494OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2K040940BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

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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