Reverso

Electrosurgical, Cutting & Coagulation & Accessories

Intelis Instruments Ltd.

The following data is part of a premarket notification filed by Intelis Instruments Ltd. with the FDA for Reverso.

Pre-market Notification Details

• Device ID: K212107
• 510k Number: K212107
• Device Name: Reverso
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: Intelis Instruments Ltd. HaOman 12 Hadera, IL 3850172
• Contact: Amit Goren
• Correspondent: Amit Goren; A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Suite 21 Kfar Saba, IL 4442518
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-07-06
• Decision Date: 2021-11-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290018977064	K212107	000
08434251002667	K212107	000
18434251002640	K212107	000
18434251002657	K212107	000
18434251002718	K212107	000
18434251002725	K212107	000
18434251002831	K212107	000
07290018977002	K212107	000
07290018977019	K212107	000
07290018977026	K212107	000
07290018977033	K212107	000
07290018977040	K212107	000
07290018977057	K212107	000
08434251002636	K212107	000