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510(k) K223682

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit by Sirius Medical Systems B.V. — Product Code PBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2023
Date Received
December 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Tissue Marker
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.

Other clearances by Sirius Medical Systems B.V.

  • K222643 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (October 19, 2022)
  • K200734 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (February 24, 2021)

Other clearances for product code PBY

  • K222643 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (October 19, 2022)
  • K200734 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (February 24, 2021)
  • K163667 — RFID Localization System- Localizer Reader, RFID Localization System- Localizer (April 28, 2017)
  • K163541 — Magseed Magnetic Marker System (January 13, 2017)
  • K153044 — Sentimag System, Sentimark Magnetic Marker Systerm (March 2, 2016)
  • K120804 — CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM (February 4, 2013)