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FDA 510(k)

WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA

K-Number: K953086 · 1995-09-22

ApplicantWoodbine Optical Corp.
Decision Date1995-09-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Woodbine Optical Corp.. It received FDA 510(k) clearance on 1995-09-22 under 510(k) number K953086. 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 WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA?

WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is Woodbine Optical Corp.. The 510(k) number is K953086.

When did WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA receive FDA 510(k) clearance?

WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA received FDA 510(k) clearance on 1995-09-22, under 510(k) number K953086.

Who is the listed applicant for WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA?

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

What is the FDA product code for WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA?

The FDA product code for WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA is GCJ.

Related Clinical Trials

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Other records listing Woodbine Optical Corp. 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.

K970917SOLOS 10MM OPERATING LAPAROSCOPEK970056SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIESK951522WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERAK940988ACCESSORIES, SURGICAL CAMERA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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