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FDA 510(k)

OLYMPUS GF-UM3/EU-M3

K-Number: K882061 · 1988-11-15

ApplicantOlympus Corp.
Decision Date1988-11-15
Product CodeGDB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS GF-UM3/EU-M3 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1988-11-15 under 510(k) number K882061. The device is classified under product code GDB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS GF-UM3/EU-M3?

OLYMPUS GF-UM3/EU-M3 is a medical device that received FDA 510(k) clearance on 1988-11-15. The listed applicant is Olympus Corp.. The 510(k) number is K882061.

When did OLYMPUS GF-UM3/EU-M3 receive FDA 510(k) clearance?

OLYMPUS GF-UM3/EU-M3 received FDA 510(k) clearance on 1988-11-15, under 510(k) number K882061.

Who is the listed applicant for OLYMPUS GF-UM3/EU-M3?

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

What is the FDA product code for OLYMPUS GF-UM3/EU-M3?

The FDA product code for OLYMPUS GF-UM3/EU-M3 is GDB.

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Other records listing Olympus Corp. 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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Related Devices (Code: GDB)

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.

K032283DESIGNS FOR VISION FIBEROPTIC LIGHTDesigns For Vision, Inc.K961536FLEXSCOPEMatrix Medica, Inc.K935818ENDOSCOPECuda Products Co.K855151FRITCH OPHTHALMIC ENDOSCOPERegtecK843900FOCUSCOPE UNIVERSAL SYSTEMMedical Diagnostics, Ca.K810007PENTAX UPPER G.I. FIBERSCOPE, #FG-34Pentax Precision Instrument Corp.

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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