Home / 510(k) Clearances / K053495

510(k) K053495

EQUIPMENT SLUSH DRAPE by Advance Medical Designs, Inc. — Product Code KKX

K053495 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "EQUIPMENT SLUSH DRAPE". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
December 15, 2005
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 Advance Medical Designs, Inc.

  • K223689 — Disposable Needle Guides and Grids (August 2, 2023)
  • K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel (October 25, 2017)
  • K011265 — ULTRASOUND TRANSDUCER COVER (October 30, 2001)
  • K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH (September 18, 2001)
  • K011422 — SURGICAL DRAPES (July 10, 2001)
  • K003670 — PATIENT DRAPE, SURGICAL (January 26, 2001)
  • K911884 — ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES (July 5, 1994)
  • K925115 — AMD DENTIST AND HYGIENIST KITS (July 5, 1994)
  • K915301 — ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK (December 11, 1992)
  • K911732 — ADVANCE DISPOSABLE CONTROL SYRINGE (September 16, 1991)

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