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FDA 510(k)

3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad

K-Number: K200835 · 2020-09-04

Applicant3M Company
Decision Date2020-09-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2020-09-04 under approval number K200835. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad?

3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by 3M Company. The 510(k) number is K200835.

When was 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad approved by the FDA?

3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad received FDA 510(k) clearance on 2020-09-04, under approval number K200835.

What company makes 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad?

3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad is manufactured by 3M Company.

What is the FDA product code for 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad?

The FDA product code for 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad is FRO. This falls under the Anesthesiology category.

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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.