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FDA 510(k)

AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM

K-Number: K083211 · 2008-12-15

ApplicantSurgiquest, Inc.
Decision Date2008-12-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgiquest, Inc.. It received FDA 510(k) clearance on 2008-12-15 under 510(k) number K083211. 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 AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM?

AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-15. The listed applicant is Surgiquest, Inc.. The 510(k) number is K083211.

When did AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM receive FDA 510(k) clearance?

AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM received FDA 510(k) clearance on 2008-12-15, under 510(k) number K083211.

Who is the listed applicant for AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM?

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

What is the FDA product code for AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM?

The FDA product code for AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM is GCJ.

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Other records listing Surgiquest, 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.

K132169SURGIQUEST AIRSEAL IFSK121336MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000K103692SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000K100180SURGIQUEST ANCHORPORT SIL KITK092504SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEMK071571SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA 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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