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510(k) K091343

MRI NEURO DRAPE by Surgivision, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2009
Date Received
May 6, 2009
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 Surgivision, Inc.

  • K102101 — SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (January 26, 2011)
  • K100836 — CLEARPOINT SYSTEM (June 16, 2010)
  • K091439 — HEAD FIXATION ARC AND TABLE BASE (August 25, 2009)

Other clearances for product code KKX

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  • 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)