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FDA 510(k)

SOLOS 10MM OPERATING LAPAROSCOPE

K-Number: K970917 · 1997-06-10

ApplicantWoodbine Optical Corp.
Decision Date1997-06-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOLOS 10MM OPERATING LAPAROSCOPE 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 1997-06-10 under 510(k) number K970917. 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 SOLOS 10MM OPERATING LAPAROSCOPE?

SOLOS 10MM OPERATING LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1997-06-10. The listed applicant is Woodbine Optical Corp.. The 510(k) number is K970917.

When did SOLOS 10MM OPERATING LAPAROSCOPE receive FDA 510(k) clearance?

SOLOS 10MM OPERATING LAPAROSCOPE received FDA 510(k) clearance on 1997-06-10, under 510(k) number K970917.

Who is the listed applicant for SOLOS 10MM OPERATING LAPAROSCOPE?

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 SOLOS 10MM OPERATING LAPAROSCOPE?

The FDA product code for SOLOS 10MM OPERATING LAPAROSCOPE is GCJ.

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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.

K970056SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIESK953086WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERAK951522WOODBINE/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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