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FDA 510(k)

SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET

K-Number: K902773 · 1990-07-16

ApplicantMedical Engineering Corp.
Decision Date1990-07-16
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K902773. 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 SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET?

SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET is a medical device that received FDA 510(k) clearance on 1990-07-16. The listed applicant is Medical Engineering Corp.. The 510(k) number is K902773.

When did SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET receive FDA 510(k) clearance?

SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET received FDA 510(k) clearance on 1990-07-16, under 510(k) number K902773.

Who is the listed applicant for SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET?

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

What is the FDA product code for SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET?

The FDA product code for SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET is FGB.

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Other records listing Medical Engineering 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.

K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEMK881736SURGITEK CO2 DELIVERY SYSTEM

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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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