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FDA 510(k)

APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE

K-Number: K012951 · 2001-11-09

ApplicantCircon Video
Decision Date2001-11-09
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012951. 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 APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE?

APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Circon Video. The 510(k) number is K012951.

When did APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE receive FDA 510(k) clearance?

APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012951.

Who is the listed applicant for APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE?

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 APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE?

The FDA product code for APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE is FGB.

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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-2K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROSK012929FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735K012925DUR-8, MODELS DUR-8K012265METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088

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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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