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510(k) K864697

CK 6000 SERIES, TOWELS by Currie Medical Specialties, Inc. — Product Code KKX

K864697 is an FDA 510(k) premarket notification submitted by Currie Medical Specialties, Inc. for the device "CK 6000 SERIES, TOWELS". The FDA issued a decision of Substantially Equivalent on December 18, 1986. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Currie Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1986
Date Received
December 2, 1986
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 Currie Medical Specialties, Inc.

  • K151158 — ALP VasQcare Take Home System (December 10, 2015)
  • K143317 — Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (January 20, 2015)
  • K140092 — CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) (April 16, 2014)
  • K112311 — ALP 501 RB PUMP SYSTEM (September 1, 2011)
  • K902441 — DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) (August 23, 1990)
  • K874760 — CK 4900 SERIES, GOWN AND TOWEL PAK (December 10, 1987)
  • K872395 — CK 1600 SERIES, TOWELS (July 2, 1987)
  • K871737 — CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR (June 22, 1987)
  • K864816 — CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE (January 8, 1987)
  • K834558 — CK10000 SERIES POUCH & BAGS ETC. (September 5, 1984)

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