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FDA 510(k)

Pixie Skin Tag

K-Number: K240226 · 2024-10-18

ApplicantOystershell NV
Decision Date2024-10-18
Product CodeORE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pixie Skin Tag is a medical device manufactured by Oystershell NV. It received FDA 510(k) clearance on 2024-10-18 under approval number K240226. The device is classified under product code ORE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pixie Skin Tag?

Pixie Skin Tag is a medical device that received FDA 510(k) clearance on 2024-10-18. It is manufactured by Oystershell NV. The 510(k) number is K240226.

When was Pixie Skin Tag approved by the FDA?

Pixie Skin Tag received FDA 510(k) clearance on 2024-10-18, under approval number K240226.

What company makes Pixie Skin Tag?

Pixie Skin Tag is manufactured by Oystershell NV.

What is the FDA product code for Pixie Skin Tag?

The FDA product code for Pixie Skin Tag is ORE.

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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