Home / 510(k) Clearances / K011422

510(k) K011422

SURGICAL DRAPES by Advance Medical Designs, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2001
Date Received
May 9, 2001
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 Advance Medical Designs, Inc.

  • K223689 — Disposable Needle Guides and Grids (August 2, 2023)
  • K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel (October 25, 2017)
  • K053495 — EQUIPMENT SLUSH DRAPE (March 16, 2006)
  • K011265 — ULTRASOUND TRANSDUCER COVER (October 30, 2001)
  • K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH (September 18, 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)