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FDA 510(k)

Sterile single use tip cleaner (WK800-S10 , WK800-S20)

K-Number: K241022 · 2024-07-11

ApplicantWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Decision Date2024-07-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile single use tip cleaner (WK800-S10 , WK800-S20) is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2024-07-11 under 510(k) number K241022. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

Sterile single use tip cleaner (WK800-S10 , WK800-S20) is a medical device that received FDA 510(k) clearance on 2024-07-11. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K241022.

When did Sterile single use tip cleaner (WK800-S10 , WK800-S20) receive FDA 510(k) clearance?

Sterile single use tip cleaner (WK800-S10 , WK800-S20) received FDA 510(k) clearance on 2024-07-11, under 510(k) number K241022.

Who is the listed applicant for Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

The FDA 510(k) record lists Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile single use tip cleaner (WK800-S10 , WK800-S20)?

The FDA product code for Sterile single use tip cleaner (WK800-S10 , WK800-S20) is GEI.

Other records listing Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as applicant

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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.

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