FDA 510(k)

LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)

K-Number: K040699 · 2004-06-04

ApplicantMegadyne Medical Products, Inc.

Decision Date2004-06-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) 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 2004-06-04 under 510(k) number K040699. 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 LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)?

LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K040699.

When did LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) receive FDA 510(k) clearance?

LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040699.

Who is the listed applicant for LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)?

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 LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)?

The FDA product code for LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) 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.