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FDA 510(k)

12 URETEROSCOPES/URETERO-RENOSCOPES

K-Number: K963855 · 1997-04-03

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1997-04-03
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

12 URETEROSCOPES/URETERO-RENOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1997-04-03 under 510(k) number K963855. 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 12 URETEROSCOPES/URETERO-RENOSCOPES?

12 URETEROSCOPES/URETERO-RENOSCOPES is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K963855.

When did 12 URETEROSCOPES/URETERO-RENOSCOPES receive FDA 510(k) clearance?

12 URETEROSCOPES/URETERO-RENOSCOPES received FDA 510(k) clearance on 1997-04-03, under 510(k) number K963855.

Who is the listed applicant for 12 URETEROSCOPES/URETERO-RENOSCOPES?

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

What is the FDA product code for 12 URETEROSCOPES/URETERO-RENOSCOPES?

The FDA product code for 12 URETEROSCOPES/URETERO-RENOSCOPES is FGB.

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Other records listing Richard Wolf Medical Instruments Corp. as applicant

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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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