FDA 510(k)

ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL

K-Number: K012799 · 2001-09-04

Decision Date2001-09-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2001-09-04 under 510(k) number K012799. 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 ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL?

ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Senorx, Inc.. The 510(k) number is K012799.

When did ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL receive FDA 510(k) clearance?

ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL received FDA 510(k) clearance on 2001-09-04, under 510(k) number K012799.

Who is the listed applicant for ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL?

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 ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL?

The FDA product code for ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL 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.