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510(k) K100551

ORLOCATE SYSTEM MODEL ORL 100 by Haldor Advanced Technologies, Ltd. — Product Code LWH

K100551 is an FDA 510(k) premarket notification submitted by Haldor Advanced Technologies, Ltd. for the device "ORLOCATE SYSTEM MODEL ORL 100". The FDA issued a decision of Substantially Equivalent on August 12, 2010. 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
August 12, 2010
Date Received
February 26, 2010
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)
  • K093557 — SMARTWAND-DTX (December 18, 2009)
  • K073180 — SMARTSPONGE PLUS SYSTEM (November 19, 2007)
  • K071355 — SMARTSPONGE SYSTEM (May 24, 2007)
  • K061316 — MEDLINE SURGICAL SPONGE SCANNER (November 2, 2006)
  • K062642 — RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (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)

FDA data resources