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FDA 510(k)

URETEROSCOPE

K-Number: K915458 · 1992-01-30

ApplicantPsi Medical Products, Inc.
Decision Date1992-01-30
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Psi Medical Products, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K915458. 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 URETEROSCOPE?

URETEROSCOPE is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Psi Medical Products, Inc.. The 510(k) number is K915458.

When did URETEROSCOPE receive FDA 510(k) clearance?

URETEROSCOPE received FDA 510(k) clearance on 1992-01-30, under 510(k) number K915458.

Who is the listed applicant for URETEROSCOPE?

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

What is the FDA product code for URETEROSCOPE?

The FDA product code for URETEROSCOPE is FGB.

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Other records listing Psi Medical Products, 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.

K931779EHL PULSE GENERATORK915459FLOWMATE HAND PUMPK920410EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROBK926423S/2(TM) STOPCOCKK921415IRRIGATION TUBING SETK921253INSTRUMENT IRRIGATION PUMP

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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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