Potenza

Electrosurgical, Cutting & Coagulation & Accessories

Jeisys Medical, Inc.

The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for Potenza.

Pre-market Notification Details

• Device ID: K201685
• 510k Number: K201685
• Device Name: Potenza
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: Jeisys Medical, Inc. 307, Daeryung Techno Town 8th, Gamasan-ro 96, Geumcheon-Gu Seoul, KR 08501
• Contact: Do Hyun Kim
• Correspondent: Pamela J. Weagraff; IQVIA 18 Bridie Lane Norfolk, MA 02056
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-22
• Decision Date: 2021-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800020100191	K201685	000
18800020101140	K201685	000
18800020101157	K201685	000
18800020101164	K201685	000
18800020101171	K201685	000
18800020101188	K201685	000
18800020101195	K201685	000
18800020101201	K201685	000
08800020100221	K201685	000
08800020100238	K201685	000
08800020100245	K201685	000
08800020100252	K201685	000
08800020100269	K201685	000
08800020100207	K201685	000
08800020100214	K201685	000
18800020101133	K201685	000