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FDA 510(k)

MICROSURGE THORACOSCOPIC ACCESS SYSTEM

K-Number: K953121 · 1995-09-29

ApplicantMicrosurge, Inc.
Decision Date1995-09-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROSURGE THORACOSCOPIC ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Microsurge, Inc.. It received FDA 510(k) clearance on 1995-09-29 under 510(k) number K953121. 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 MICROSURGE THORACOSCOPIC ACCESS SYSTEM?

MICROSURGE THORACOSCOPIC ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Microsurge, Inc.. The 510(k) number is K953121.

When did MICROSURGE THORACOSCOPIC ACCESS SYSTEM receive FDA 510(k) clearance?

MICROSURGE THORACOSCOPIC ACCESS SYSTEM received FDA 510(k) clearance on 1995-09-29, under 510(k) number K953121.

Who is the listed applicant for MICROSURGE THORACOSCOPIC ACCESS SYSTEM?

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

What is the FDA product code for MICROSURGE THORACOSCOPIC ACCESS SYSTEM?

The FDA product code for MICROSURGE THORACOSCOPIC ACCESS SYSTEM is GCJ.

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Other records listing Microsurge, 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.

K964109MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIPK960554DETACHATIP THORACOSCOPIC SCISSORSK955408MICROSURGE THORACOSCOPIC INSTRUMENTSK954641ENDO-LEADERK954072MICROSURGE PUNCTURE CLOSE DEVICEK954520MICROSURGE VERESS NEEDLE

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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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