Encision AEM Monopolar Laparoscopic Instruments And Accessories

Electrosurgical, Cutting & Coagulation & Accessories

Encision Incorporated

The following data is part of a premarket notification filed by Encision Incorporated with the FDA for Encision Aem Monopolar Laparoscopic Instruments And Accessories.

Pre-market Notification Details

• Device ID: K191612
• 510k Number: K191612
• Device Name: Encision AEM Monopolar Laparoscopic Instruments And Accessories
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: Encision Incorporated 6797 Winchester Circle Boulder, CO 80301
• Contact: Denise Baker
• Correspondent: Charles M. (mike) Hart; HART Consulting LLC 615 Reid Place Castle Rock, CO 80108
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-17
• Decision Date: 2020-03-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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