FDA 510(k)

E-Z CLEAN LAPAROSCOPIC ELECTRODE

K-Number: K913281 · 1991-08-16

ApplicantMegadyne Medical Products, Inc.

Decision Date1991-08-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

E-Z CLEAN LAPAROSCOPIC ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K913281. 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 E-Z CLEAN LAPAROSCOPIC ELECTRODE?

E-Z CLEAN LAPAROSCOPIC ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K913281.

When did E-Z CLEAN LAPAROSCOPIC ELECTRODE receive FDA 510(k) clearance?

E-Z CLEAN LAPAROSCOPIC ELECTRODE received FDA 510(k) clearance on 1991-08-16, under 510(k) number K913281.

Who is the listed applicant for E-Z CLEAN LAPAROSCOPIC ELECTRODE?

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

What is the FDA product code for E-Z CLEAN LAPAROSCOPIC ELECTRODE?

The FDA product code for E-Z CLEAN LAPAROSCOPIC ELECTRODE is GEI.

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Other records listing Megadyne Medical Products, Inc. as applicant

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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.