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FDA 510(k)

ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS

K-Number: K081647 · 2008-08-12

ApplicantXodus Medical, Inc.
Decision Date2008-08-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Xodus Medical, Inc.. It received FDA 510(k) clearance on 2008-08-12 under 510(k) number K081647. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS?

ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS is a medical device that received FDA 510(k) clearance on 2008-08-12. The listed applicant is Xodus Medical, Inc.. The 510(k) number is K081647.

When did ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS receive FDA 510(k) clearance?

ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS received FDA 510(k) clearance on 2008-08-12, under 510(k) number K081647.

Who is the listed applicant for ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS?

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

What is the FDA product code for ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS?

The FDA product code for ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS is GEI.

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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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