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PBY — Temporary Tissue Marker Class II

FDA Device Classification

Classification Details

Product Code
PBY
Device Class
Class II
Regulation Number
878.4300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223682sirius medical systemsSirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitNovember 9, 2023
K222643sirius medical systemsSirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitOctober 19, 2022
K200734sirius medical systemsSirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitFebruary 24, 2021
K163667health beaconsRFID Localization System- Localizer Reader, RFID Localization System- Localizer April 28, 2017
K163541endomagnetics ltdMagseed Magnetic Marker SystemJanuary 13, 2017
K153044endomagnetics ltdSentimag System, Sentimark Magnetic Marker SystermMarch 2, 2016
K120804cianna medicalCIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEMFebruary 4, 2013