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510(k) K093557

SMARTWAND-DTX by Clearcount Medical Solutions — Product Code LWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2009
Date Received
November 16, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Counter, Sponge, Surgical
Device Class
Class I
Regulation Number
880.2740
Review Panel
SU
Submission Type

Other clearances by Clearcount Medical Solutions

  • K073180 — SMARTSPONGE PLUS SYSTEM (November 19, 2007)
  • K071355 — SMARTSPONGE SYSTEM (May 24, 2007)

Other clearances for product code LWH

  • K121274 — PIXEL APP (June 27, 2012)
  • K120473 — PIXEL APP (April 9, 2012)
  • K100551 — ORLOCATE SYSTEM MODEL ORL 100 (August 12, 2010)
  • K073180 — SMARTSPONGE PLUS SYSTEM (November 19, 2007)
  • K071355 — SMARTSPONGE SYSTEM (May 24, 2007)
  • K062642 — RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (November 2, 2006)
  • K061316 — MEDLINE SURGICAL SPONGE SCANNER (November 2, 2006)
  • K060076 — SURGICOUNT SAFETY-SPONGE SYSTEM (March 14, 2006)
  • K982260 — MARKWELL GAUZE SPONGE (August 12, 1998)
  • K972302 — POCKET COUNT OR SAFETCOUNT (July 25, 1997)