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FDA 510(k)

MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000

K-Number: K121336 · 2012-07-03

ApplicantSurgiquest, Inc.
Decision Date2012-07-03
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Surgiquest, Inc.. It received FDA 510(k) clearance on 2012-07-03 under 510(k) number K121336. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000?

MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 is a medical device that received FDA 510(k) clearance on 2012-07-03. The listed applicant is Surgiquest, Inc.. The 510(k) number is K121336.

When did MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 receive FDA 510(k) clearance?

MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 received FDA 510(k) clearance on 2012-07-03, under 510(k) number K121336.

Who is the listed applicant for MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000?

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 MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000?

The FDA product code for MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 is HIF.

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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 IFSK103692SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000K100180SURGIQUEST ANCHORPORT SIL KITK092504SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEMK083211AIRSEAL OPTICAL TROCAR & CANNULA SYSTEMK071571SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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