FDA 510(k)

AC Cream - Conductive paste

K-Number: K212326 · 2021-12-01

Decision Date2021-12-01

Product CodeGYB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AC Cream - Conductive paste is a medical device manufactured by Spes Medica Srl. It received FDA 510(k) clearance on 2021-12-01 under approval number K212326. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AC Cream - Conductive paste?

AC Cream - Conductive paste is a medical device that received FDA 510(k) clearance on 2021-12-01. It is manufactured by Spes Medica Srl. The 510(k) number is K212326.

When was AC Cream - Conductive paste approved by the FDA?

AC Cream - Conductive paste received FDA 510(k) clearance on 2021-12-01, under approval number K212326.

What company makes AC Cream - Conductive paste?

AC Cream - Conductive paste is manufactured by Spes Medica Srl.

What is the FDA product code for AC Cream - Conductive paste?

The FDA product code for AC Cream - Conductive paste is GYB.

Other Devices by Spes Medica Srl

K192603Spes Medica Subdermal Needle Electrodes K190050Tech Dots - Adhesive and conductive gel K192606SAC2 - Electrode Cream K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

Related Devices (Code: GYB)

K161654NuFACE Gel PrimerCarol Cole Company K161715EndyGelEndymed Medical, Ltd. K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl K200402DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. K191975Elefix V Paste for EEG & EMGNihon Kohden Corporation K192606SAC2 - Electrode CreamSpes Medica Srl

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.