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FDA 510(k)

FLEXIBLE URETEROSCOPE

K-Number: K964482 · 1997-01-24

ApplicantApplied Fiberoptics, Inc.
Decision Date1997-01-24
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE URETEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Fiberoptics, Inc.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964482. 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 FLEXIBLE URETEROSCOPE?

FLEXIBLE URETEROSCOPE is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Applied Fiberoptics, Inc.. The 510(k) number is K964482.

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

FLEXIBLE URETEROSCOPE received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964482.

Who is the listed applicant for FLEXIBLE URETEROSCOPE?

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

What is the FDA product code for FLEXIBLE URETEROSCOPE?

The FDA product code for FLEXIBLE URETEROSCOPE is FGB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Applied Fiberoptics, 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.

K964037FLEXIBLE CYSTOSCOPEK820621NASAL INSTRUMENTS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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