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510(k) K141318

CIANNA MEDICAL SGS SYSTEM by Cianna Medical, Inc. — Product Code PDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2014
Date Received
May 20, 2014
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.

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  • K132463 — CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM (December 3, 2013)
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  • K101411 — SAVI PREPARATION DEVICE (July 12, 2010)
  • K081677 — SAVI APPLICATOR KIT (July 22, 2008)
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Other clearances for product code PDW

  • K161507 — Cianna Medical SAVI Scout Reflector and SAVI Scout System (July 29, 2016)
  • DEN130004 — MOERAE SURGICAL MARKING PEN (December 18, 2014)