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FDA 510(k)

FLEXIBLADE

K-Number: K984101 · 1999-09-03

ApplicantArco Medic , Ltd.
Decision Date1999-09-03
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXIBLADE is the device name listed in this FDA 510(k) record. The listed applicant is Arco Medic , Ltd.. It received FDA 510(k) clearance on 1999-09-03 under 510(k) number K984101. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLADE?

FLEXIBLADE is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Arco Medic , Ltd.. The 510(k) number is K984101.

When did FLEXIBLADE receive FDA 510(k) clearance?

FLEXIBLADE received FDA 510(k) clearance on 1999-09-03, under 510(k) number K984101.

Who is the listed applicant for FLEXIBLADE?

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

What is the FDA product code for FLEXIBLADE?

The FDA product code for FLEXIBLADE is CCW.

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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.

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