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510(k) K042893

UNDER BUTTOCKS DRAPE by International Medsurg Connection, Inc. — Product Code KKX

K042893 is an FDA 510(k) premarket notification submitted by International Medsurg Connection, Inc. for the device "UNDER BUTTOCKS DRAPE". The FDA issued a decision of Substantially Equivalent on March 11, 2005. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. International Medsurg Connection, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2005
Date Received
October 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical, Antimicrobial
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Other clearances by International Medsurg Connection, Inc.

  • K110656 — IMC BLOOD COLLECTION NEEDLE (August 18, 2011)
  • K110882 — IMC INSULIN SYRINGE (August 18, 2011)
  • K102584 — IMC HYPODERMIC NEEDLE (January 14, 2011)
  • K102969 — IMC PISTON SYRINGES (December 20, 2010)
  • K100991 — IMC SURGICAL DRAPE (October 5, 2010)
  • K100846 — IMC SURGICAL FACE MASK (August 16, 2010)
  • K100208 — IMC SURGICAL DRAPE (April 20, 2010)
  • K052169 — IMC SURGICAL DRAPES (November 17, 2005)
  • K023808 — IRRIGATION SETS (March 10, 2003)
  • K022159 — PISTON SYRINGE & HYPODERMIC NEEDLE (November 7, 2002)

Other clearances for product code KKX

  • K230645 — BeneHold™ Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)

FDA data resources