Home / 510(k) Clearances / K163667

510(k) K163667

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) by Health Beacons, Inc. — Product Code PBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2017
Date Received
December 27, 2016
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 Health Beacons, Inc.

  • K193189 — RFID Localization System (May 6, 2020)
  • K190932 — RFID Localization System (September 13, 2019)
  • K181692 — 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicat (September 25, 2018)

Other clearances for product code PBY

  • K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (November 9, 2023)
  • 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)
  • 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)