Apyx

Fixation, Non-absorbable Or Absorbable, For Pelvic Use

Escala Medical

The following data is part of a premarket notification filed by Escala Medical with the FDA for Apyx.

Pre-market Notification Details

• Device ID: K213783
• 510k Number: K213783
• Device Name: Apyx
• Classification: Fixation, Non-absorbable Or Absorbable, For Pelvic Use
• Applicant: Escala Medical 17th Tchelet Street Misgav Industrial Park, IL 2017400
• Contact: Edit Goldberg
• Correspondent: Jonathan Kahan; Hogan Lovells 555 Thirteenth Street, NW Washington, DC 20004 -1109
• Product Code: PBQ
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-03
• Decision Date: 2022-04-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290019174066	K213783	000
07290019174103	K213783	000
07290019174110	K213783	000
07290019174127	K213783	000
07290019174134	K213783	000
07290019174141	K213783	000
07290019174158	K213783	000
07290019174165	K213783	000
07290019174172	K213783	000
07290019174189	K213783	000
07290019174196	K213783	000
07290019174202	K213783	000
07290019174035	K213783	000
07290019174042	K213783	000
07290019174059	K213783	000
07290019174028	K213783	000
07290019174011	K213783	000
07290019174097	K213783	000