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510(k) K163667

Device
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)
Applicant
HEALTH BEACONS, INC.
510(k) number
K163667
Product code
PBY  
Decision
Substantially Equivalent (SESE)
Decision date
2017-04-28
Date received
2016-12-27
Regulation
878.4300
Classification name
Temporary Tissue Marker
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NANCY CONFREY
Address
34 Walden St. #753 Concord MA US 01742 01742

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PBY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223682Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.2023-11-09
K222643Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.2022-10-19
K200734Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSirius Medical Systems B.V.2021-02-24
K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,2017-01-13
K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,2016-03-02
K120804CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEMCianna Medical2013-02-04

Legacy Summary#

summary

FDA Review#

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