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510(k) K974647

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 by Customed, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1998
Date Received
December 12, 1997
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.

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  • K953678 — STERIMED STERIZATION WRAPPER (NON-STERILE) (October 2, 1995)
  • K950295 — WOUND CLOSURE/LACERATION TRAY (April 18, 1995)
  • K942177 — FOLEY CATHETERIZATION TRAY (September 8, 1994)
  • K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)

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  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
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  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)