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510(k) K120804

Device
CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
Applicant
CIANNA MEDICAL
510(k) number
K120804
Product code
PBY  
Decision
Substantially Equivalent (SESE)
Decision date
2013-02-04
Date received
2012-03-16
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
GARY MOCNIK
Address
6 Journey, Suite 125 Aliso Viejo CA US 92656 92656

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
K163667RFID 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)Health Beacons, Inc.2017-04-28
K163541Magseed Magnetic Marker SystemEndomagnetics Ltd.,2017-01-13
K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,2016-03-02

Legacy Summary#

summary

FDA Review#

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