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FDA 510(k)

ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)

K-Number: K970039 · 1997-02-26

ApplicantMedtrex, Inc.
Decision Date1997-02-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) is the device name listed in this FDA 510(k) record. The listed applicant is Medtrex, Inc.. It received FDA 510(k) clearance on 1997-02-26 under 510(k) number K970039. 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 ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)?

ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Medtrex, Inc.. The 510(k) number is K970039.

When did ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) receive FDA 510(k) clearance?

ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) received FDA 510(k) clearance on 1997-02-26, under 510(k) number K970039.

Who is the listed applicant for ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)?

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

What is the FDA product code for ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)?

The FDA product code for ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) is GEI.

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Other records listing Medtrex, Inc. as applicant

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Official Source

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