Cleared Traditional

K223682 - Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223682 · Sirius Medical Systems B.V. · General & Plastic Surgery device
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Nov 2023
Decision
336d
Days
Class 2
Risk

K223682 is an FDA 510(k) clearance for the Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit. Classified as Temporary Tissue Marker (product code PBY), Class II - Special Controls.

Submitted by Sirius Medical Systems B.V. (Eindhoven, NL). The FDA issued a Cleared decision on November 9, 2023 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. 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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K223682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2022
Decision Date November 09, 2023
Days to Decision 336 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 114d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBY Temporary Tissue Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.