Home / 510(k) Clearances / K120804

510(k) K120804

CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM by Cianna Medical — Product Code PBY

K120804 is an FDA 510(k) premarket notification submitted by Cianna Medical for the device "CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 2013. The device falls under product code PBY (Temporary Tissue Marker), a Class II device regulated under 21 CFR 878.4300. Cianna Medical has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2013
Date Received
March 16, 2012
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 Cianna Medical

  • K181007 — Cianna Medical SAVI Scout Reflector and SAVI Scout System (August 2, 2018)
  • K171767 — Cianna Medical SAVI Scout Reflector and SAVI Scout System (October 31, 2017)
  • K161507 — Cianna Medical SAVI Scout Reflector and SAVI Scout System (July 29, 2016)
  • K141318 — CIANNA MEDICAL SGS SYSTEM (August 27, 2014)
  • K132463 — CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM (December 3, 2013)
  • K103215 — CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT (November 15, 2010)
  • K101411 — SAVI PREPARATION DEVICE (July 12, 2010)
  • K081677 — SAVI APPLICATOR KIT (July 22, 2008)
  • K080565 — MODIFICATION TO: SAVI APPLICATOR KIT (April 4, 2008)

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)
  • 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)

FDA data resources