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FDA 510(k)

ULTRATHIN URETEROSCOPES

K-Number: K951855 · 1995-08-16

ApplicantOlympus America, Inc.
Decision Date1995-08-16
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRATHIN URETEROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1995-08-16 under 510(k) number K951855. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRATHIN URETEROSCOPES?

ULTRATHIN URETEROSCOPES is a medical device that received FDA 510(k) clearance on 1995-08-16. The listed applicant is Olympus America, Inc.. The 510(k) number is K951855.

When did ULTRATHIN URETEROSCOPES receive FDA 510(k) clearance?

ULTRATHIN URETEROSCOPES received FDA 510(k) clearance on 1995-08-16, under 510(k) number K951855.

Who is the listed applicant for ULTRATHIN URETEROSCOPES?

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

What is the FDA product code for ULTRATHIN URETEROSCOPES?

The FDA product code for ULTRATHIN URETEROSCOPES is FGB.

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Other records listing Olympus America, Inc. 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: FGB)

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.

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

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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