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FDA 510(k)

I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA

K-Number: K934097 · 1994-02-07

ApplicantSharplan Lasers, Inc.
Decision Date1994-02-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1994-02-07 under 510(k) number K934097. 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 I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA?

I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA is a medical device that received FDA 510(k) clearance on 1994-02-07. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K934097.

When did I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA receive FDA 510(k) clearance?

I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA received FDA 510(k) clearance on 1994-02-07, under 510(k) number K934097.

Who is the listed applicant for I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA?

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

What is the FDA product code for I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA?

The FDA product code for I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA is GCJ.

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Other records listing Sharplan Lasers, 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.

K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMK971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K971648SHARPLAN ERBIUM: YAG LASER (4020)K971743SHARPLAN CO2 SURGICAL LASER SYSTEMK962446SHARPLAN RUBY LASER SYSTEM

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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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