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FDA 510(k)

STORZ/URBAN SURGICAL MICROSCOPE SYSTEM

K-Number: K844858 · 1985-03-25

ApplicantStorz Instrument Co.
Decision Date1985-03-25
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STORZ/URBAN SURGICAL MICROSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Storz Instrument Co.. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K844858. The device is classified under product code EPT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STORZ/URBAN SURGICAL MICROSCOPE SYSTEM?

STORZ/URBAN SURGICAL MICROSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Storz Instrument Co.. The 510(k) number is K844858.

When did STORZ/URBAN SURGICAL MICROSCOPE SYSTEM receive FDA 510(k) clearance?

STORZ/URBAN SURGICAL MICROSCOPE SYSTEM received FDA 510(k) clearance on 1985-03-25, under 510(k) number K844858.

Who is the listed applicant for STORZ/URBAN SURGICAL MICROSCOPE SYSTEM?

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

What is the FDA product code for STORZ/URBAN SURGICAL MICROSCOPE SYSTEM?

The FDA product code for STORZ/URBAN SURGICAL MICROSCOPE SYSTEM is EPT.

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Other records listing Storz Instrument 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.

K980100STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACKK980488STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEMK972664STORZ MILLENNIUM VISCOUS FLUID SYSTEMK971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLESK964743STORZ E8010 ERGOTEC/PREMIERE ADAPTORK960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH

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Related Devices (Code: EPT)

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.

K942233MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEMCarl Zeiss, Inc.K931284MICRODYNE OFFICE SURGICAL MICROSCOPEMicrodyne, Inc.K933310MICRINS CONTRAST BACKGROUND MATERIALMicrins Surgical, Inc.K903412STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.Storz Instrument Co.K883581OPMI CSCarl Zeiss, Inc.K882269STORZ DIAGNOSTIC MICROSCOPE SYSTEMStorz Instrument Co.

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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