Home / 510(k) Clearances / K161507

510(k) K161507

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2016
Date Received
June 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Internal Tissue Marker
Device Class
Class II
Regulation Number
878.4670
Review Panel
SU
Submission Type

An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

Other clearances by Cianna Medical, Inc.

  • 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)
  • 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)

Other clearances for product code PDW

  • DEN130004 — MOERAE SURGICAL MARKING PEN (December 18, 2014)
  • K141318 — CIANNA MEDICAL SGS SYSTEM (August 27, 2014)