Cleared Traditional

K240226 - Pixie Skin Tag (FDA 510(k) Clearance)

K240226 · Oystershell NV · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
266d
Days
-
Risk

K240226 is an FDA 510(k) clearance for the Pixie Skin Tag.

Submitted by Oystershell NV (Merelbeke, BE). The FDA issued a Cleared decision on October 18, 2024 after a review of 266 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Oystershell NV devices

Submission Details

510(k) Number K240226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2024
Decision Date October 18, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 114d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ORE
Device Class -