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510(k) K945144

SPONGE COUNT by Michael Fischer Assoc. — Product Code LWH

K945144 is an FDA 510(k) premarket notification submitted by Michael Fischer Assoc. for the device "SPONGE COUNT". The FDA issued a decision of Substantially Equivalent on January 12, 1995. 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
January 12, 1995
Date Received
October 20, 1994
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

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  • 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)
  • K060076 — SURGICOUNT SAFETY-SPONGE SYSTEM (March 14, 2006)
  • K982260 — MARKWELL GAUZE SPONGE (August 12, 1998)

FDA data resources