Cleared Special

K222643 - Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

K222643 is an FDA 510(k) clearance for Sirius Pintuition Seed, manufactured by Sirius Medical Systems B.V.. The device is a Class 2 General & Plastic Surgery device with product code PBY cleared through the Special 510(k) pathway after a 48-day FDA review.

K222643 · Sirius Medical Systems B.V. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2022
Decision
48d
Days
Class 2
Risk

K222643 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 October 19, 2022 after a review of 48 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sirius Medical Systems B.V. devices

FDA 510(k) Submission Details - K222643

510(k) Number K222643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2022
Decision Date October 19, 2022
Days to Decision 48 days
Submission Type Special
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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

PBY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PBY Temporary Tissue Marker

Devices cleared under the same product code (PBY) and FDA review panel - the closest regulatory comparables to K222643.
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K223682 · Sirius Medical Systems B.V. · Nov 2023
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K200734 · Sirius Medical Systems B.V. · Feb 2021
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
K163667 · Health Beacons, Inc. · Apr 2017
Magseed Magnetic Marker System
K163541 · Endomagnetics Ltd., · Jan 2017
Sentimag System, Sentimark Magnetic Marker Systerm
K153044 · Endomagnetics Ltd., · Mar 2016
CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
K120804 · Cianna Medical · Feb 2013