FDA 510(k)

NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515

K-Number: K071819 · 2007-07-26

Decision Date2007-07-26

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 is the device name listed in this FDA 510(k) record. The listed applicant is Ncontact Surgical, Inc.. It received FDA 510(k) clearance on 2007-07-26 under 510(k) number K071819. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515?

NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 is a medical device that received FDA 510(k) clearance on 2007-07-26. The listed applicant is Ncontact Surgical, Inc.. The 510(k) number is K071819.

When did NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 receive FDA 510(k) clearance?

NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 received FDA 510(k) clearance on 2007-07-26, under 510(k) number K071819.

Who is the listed applicant for NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515?

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

What is the FDA product code for NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515?

The FDA product code for NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 is OCL.

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Other records listing Ncontact Surgical, Inc. as applicant

K120857EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX K090202NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 K082203NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 K063012NCONTACT COAGULATION SYSTEM KIT, MODEL CSK K062539NCONTACT COAGULATION SYSTEM KIT

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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.