FDA 510(k)

EASY GUIDE ELECTROSURGICAL ACCESS DEVICE

K-Number: K012004 · 2001-09-25

Decision Date2001-09-25

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EASY GUIDE ELECTROSURGICAL ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2001-09-25 under 510(k) number K012004. 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 EASY GUIDE ELECTROSURGICAL ACCESS DEVICE?

EASY GUIDE ELECTROSURGICAL ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2001-09-25. The listed applicant is Senorx, Inc.. The 510(k) number is K012004.

When did EASY GUIDE ELECTROSURGICAL ACCESS DEVICE receive FDA 510(k) clearance?

EASY GUIDE ELECTROSURGICAL ACCESS DEVICE received FDA 510(k) clearance on 2001-09-25, under 510(k) number K012004.

Who is the listed applicant for EASY GUIDE ELECTROSURGICAL ACCESS DEVICE?

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

What is the FDA product code for EASY GUIDE ELECTROSURGICAL ACCESS DEVICE?

The FDA product code for EASY GUIDE ELECTROSURGICAL ACCESS DEVICE 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.