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FDA 510(k)

MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS

K-Number: K011849 · 2001-12-10

ApplicantCircon Video
Decision Date2001-12-10
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 2001-12-10 under 510(k) number K011849. 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 MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS?

MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS is a medical device that received FDA 510(k) clearance on 2001-12-10. The listed applicant is Circon Video. The 510(k) number is K011849.

When did MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS receive FDA 510(k) clearance?

MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS received FDA 510(k) clearance on 2001-12-10, under 510(k) number K011849.

Who is the listed applicant for MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS?

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

What is the FDA product code for MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS?

The FDA product code for MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS 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 Circon Video 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.

K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,K011876DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2K012929FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPEK012925DUR-8, MODELS DUR-8K012265METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088

View all 14 devices →

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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