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510(k) K200238

ControlRad Sterile Cover by Controlrad, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2020
Date Received
January 31, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Controlrad, Inc.

  • K213455 — ControlRad Select Model Z (November 24, 2021)
  • K211782 — ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 (July 1, 2021)
  • K202431 — ControlRad Select Model Z (December 23, 2020)
  • K200663 — ControlRad Trace Model 9 (June 24, 2020)
  • K183109 — ControlRad Trace Model 8 (May 13, 2019)

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)
  • 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)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (July 25, 2014)