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FDA 510(k)

CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT

K-Number: K911053 · 1991-06-03

ApplicantCircon Video
Decision Date1991-06-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 1991-06-03 under 510(k) number K911053. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT?

CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Circon Video. The 510(k) number is K911053.

When did CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT receive FDA 510(k) clearance?

CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT received FDA 510(k) clearance on 1991-06-03, under 510(k) number K911053.

Who is the listed applicant for CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT?

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 CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT?

The FDA product code for CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT is GCJ.

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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- 735K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPEK012925DUR-8, MODELS DUR-8

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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