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FDA 510(k)

OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES

K-Number: K945266 · 1995-02-23

ApplicantOptus, Inc.
Decision Date1995-02-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1995-02-23 under 510(k) number K945266. 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 OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES?

OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Optus, Inc.. The 510(k) number is K945266.

When did OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES receive FDA 510(k) clearance?

OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES received FDA 510(k) clearance on 1995-02-23, under 510(k) number K945266.

Who is the listed applicant for OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES?

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

What is the FDA product code for OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES?

The FDA product code for OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES is GCJ.

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Other records listing Optus, 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.

K945264OPTUS OTOSCOPESK953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESK945268OPTUS BRONCHOSCOPESK945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESK945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESK945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES

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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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