LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)

Electrosurgical, Cutting & Coagulation & Accessories

MEGADYNE MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Laparoscopic Electrode, Reusable Indicator Shaft (leris).

Pre-market Notification Details

• Device ID: K040699
• 510k Number: K040699
• Device Name: LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020
• Contact: Ronda Magneson
• Correspondent: Ronda Magneson; MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-03-17
• Decision Date: 2004-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30614559102323	K040699	000
30614559102415	K040699	000
30614559102262	K040699	000
30614559102255	K040699	000
30614559102224	K040699	000
30614559102217	K040699	000
30614559102200	K040699	000
30614559102194	K040699	000
30614559102187	K040699	000
30614559102422	K040699	000
30614559102439	K040699	000
30614559102316	K040699	000
30614559102309	K040699	000
30614559102293	K040699	000
30614559102286	K040699	000
30614559102279	K040699	000
30614559102248	K040699	000
30614559102231	K040699	000
30614559102446	K040699	000
30614559102170	K040699	000