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FDA 510(k)

SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9

K-Number: K880801 · 1988-05-26

ApplicantMedical Engineering Corp.
Decision Date1988-05-26
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 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 1988-05-26 under 510(k) number K880801. 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 FLEXIBLE URETEROSCOPE SU-7 & SU-9?

SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 is a medical device that received FDA 510(k) clearance on 1988-05-26. The listed applicant is Medical Engineering Corp.. The 510(k) number is K880801.

When did SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 receive FDA 510(k) clearance?

SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 received FDA 510(k) clearance on 1988-05-26, under 510(k) number K880801.

Who is the listed applicant for SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9?

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 FLEXIBLE URETEROSCOPE SU-7 & SU-9?

The FDA product code for SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 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 EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW 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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