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510(k) K121274

PIXEL APP by Gauss Surgical, Inc., — Product Code LWH

K121274 is an FDA 510(k) premarket notification submitted by Gauss Surgical, Inc., for the device "PIXEL APP". The FDA issued a decision of Substantially Equivalent on June 27, 2012. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740. Gauss Surgical, Inc., has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2012
Date Received
April 27, 2012
Clearance Type
Special
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 by Gauss Surgical, Inc.,

  • K163507 — Triton Sponge System (April 25, 2017)
  • K160338 — Triton System (August 5, 2016)
  • K142801 — Triton Canister System (March 12, 2015)
  • DEN130015 — PIXEL 3 SYSTEM (May 9, 2014)
  • K120473 — PIXEL APP (April 9, 2012)

Other clearances for product code LWH

  • 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)
  • K972302 — POCKET COUNT OR SAFETCOUNT (July 25, 1997)

FDA data resources