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FDA 510(k)

RIGID URETEROSCOPE

K-Number: K901214 · 1990-06-01

ApplicantApplied Urology, Inc.
Decision Date1990-06-01
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RIGID URETEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Urology, Inc.. It received FDA 510(k) clearance on 1990-06-01 under 510(k) number K901214. 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 RIGID URETEROSCOPE?

RIGID URETEROSCOPE is a medical device that received FDA 510(k) clearance on 1990-06-01. The listed applicant is Applied Urology, Inc.. The 510(k) number is K901214.

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

RIGID URETEROSCOPE received FDA 510(k) clearance on 1990-06-01, under 510(k) number K901214.

Who is the listed applicant for RIGID URETEROSCOPE?

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

What is the FDA product code for RIGID URETEROSCOPE?

The FDA product code for RIGID URETEROSCOPE is FGB.

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Other records listing Applied Urology, 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.

K921838ACUCISE URETERAL CUTTING CATHETERK925282UROLOGICAL CATHETER AND ACCESSORIESK920695URETERAL STENTK915219URETHRAL ELECTRODE SHEATHK912093DISPOSABLE ASPIRATION IRRIGATION SYSTEMK920030SURESEAL ENDOSCOPIC VALVE

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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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