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FDA 510(k)

KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE

K-Number: K970427 · 1997-03-11

ApplicantKarl Storz Endoscopy
Decision Date1997-03-11
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K970427. 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 KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE?

KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K970427.

When did KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE receive FDA 510(k) clearance?

KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE received FDA 510(k) clearance on 1997-03-11, under 510(k) number K970427.

Who is the listed applicant for KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE?

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

What is the FDA product code for KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE?

The FDA product code for KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE is FGB.

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Other records listing Karl Storz Endoscopy 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.

K043375FISCH TITANIUM MIDDLE EAR PROSTHESESK030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIXK030009KSEA POWERSHAVER SYSTEM S2K023924AUTOCON II 200 ELECTROSURGICAL GENERATORK023187KSEA SPINOSCOPEK011700MODULITH SLK LITHOTRIPTER

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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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