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510(k) K060076

SURGICOUNT SAFETY-SPONGE SYSTEM by Surgicount Medical — Product Code LWH

K060076 is an FDA 510(k) premarket notification submitted by Surgicount Medical for the device "SURGICOUNT SAFETY-SPONGE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 14, 2006. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2006
Date Received
January 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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)
  • K093557 — SMARTWAND-DTX (December 18, 2009)
  • 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)
  • K982260 — MARKWELL GAUZE SPONGE (August 12, 1998)
  • K972302 — POCKET COUNT OR SAFETCOUNT (July 25, 1997)

FDA data resources