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FDA 510(k)

Gemini Sterilization Wrap

K-Number: K220365 · 2022-10-06

ApplicantMedline Industries, LP
Decision Date2022-10-06
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Gemini Sterilization Wrap is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2022-10-06 under approval number K220365. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gemini Sterilization Wrap?

Gemini Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2022-10-06. It is manufactured by Medline Industries, LP. The 510(k) number is K220365.

When was Gemini Sterilization Wrap approved by the FDA?

Gemini Sterilization Wrap received FDA 510(k) clearance on 2022-10-06, under approval number K220365.

What company makes Gemini Sterilization Wrap?

Gemini Sterilization Wrap is manufactured by Medline Industries, LP.

What is the FDA product code for Gemini Sterilization Wrap?

The FDA product code for Gemini Sterilization Wrap is FRG.

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Related Devices (Code: FRG)

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Official Source

View on FDA Database →

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

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