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510(k) K181007

Cianna Medical SAVI Scout Reflector and SAVI Scout System by Cianna Medical, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2018
Date Received
April 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Cianna Medical, Inc.

  • 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)
  • K120804 — CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM (February 4, 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)

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