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FDA 510(k)

STRYKER URETEROSCOPE

K-Number: K043021 · 2005-03-16

ApplicantStryker Endoscopy
Decision Date2005-03-16
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STRYKER URETEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2005-03-16 under 510(k) number K043021. 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 STRYKER URETEROSCOPE?

STRYKER URETEROSCOPE is a medical device that received FDA 510(k) clearance on 2005-03-16. The listed applicant is Stryker Endoscopy. The 510(k) number is K043021.

When did STRYKER URETEROSCOPE receive FDA 510(k) clearance?

STRYKER URETEROSCOPE received FDA 510(k) clearance on 2005-03-16, under 510(k) number K043021.

Who is the listed applicant for STRYKER URETEROSCOPE?

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

What is the FDA product code for STRYKER URETEROSCOPE?

The FDA product code for STRYKER URETEROSCOPE is FGB.

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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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