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510(k) K920341

LACERATION TRAYS by Medikmark, Inc. — Product Code KKX

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
April 23, 1992
Date Received
January 24, 1992
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 Medikmark, Inc.

  • K953474 — IV START KIT (October 2, 1995)
  • K923960 — UPPER EXTERMITY DRAPE KIT (October 7, 1994)
  • K921733 — TRACHEOSTOMY CARE TRAY (June 15, 1994)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K920339 — DRESSING CHANGE TRAY (April 23, 1992)
  • K920340 — SUTURE REMOVAL KIT (April 23, 1992)

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)