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510(k) K112791

SITESCRUB IPA DEVICE by C. R. Bard — Product Code LKB

K112791 is an FDA 510(k) premarket notification submitted by C. R. Bard for the device "SITESCRUB IPA DEVICE". The FDA issued a decision of Substantially Equivalent on February 24, 2012. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. C. R. Bard has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2012
Date Received
September 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Alcohol, Device Disinfectant
Device Class
Class U
Regulation Number
Review Panel
HO
Submission Type

Other clearances by C. R. Bard

  • K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Cath (March 5, 2020)
  • K182281 — Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Ne (October 24, 2018)
  • K172571 — ULTRASCORE Focused Force PTA Balloon (September 22, 2017)
  • K170294 — VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIG (May 1, 2017)
  • K162193 — XenMatrix AB Surgical Graft (December 23, 2016)
  • K151177 — XenMatrix AB Surgical Graft (July 30, 2015)
  • K142818 — Phasix Mesh (March 31, 2015)
  • K140501 — XENMATRIX SURGICAL GRAFT (April 28, 2014)

Other clearances for product code LKB

  • K132380 — PREVANTICS DEVICE SWAB (August 27, 2014)
  • K121655 — BD ALCOHOL SWAB (March 20, 2013)
  • K912161 — I.V. STARR KIT (October 8, 1991)
  • K912731 — STERI-SWAB (October 2, 1991)
  • K910735 — HEXIDIS ALCOHOL SWAB (April 2, 1991)
  • K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER (April 4, 1990)
  • K896835 — ALCOHOL PREP AND POVIDONE-IODINE PREP (January 11, 1990)
  • K894791 — BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE (October 3, 1989)
  • K893958 — BAXTER ACETONE-ALCOHOL PREP PADS, STERILE (October 3, 1989)
  • K892193 — QUICKPAD (ALCOHOL SWABS) (August 4, 1989)

FDA data resources