510(k) K003670

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 26, 2001
Date Received: November 28, 2000
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)
K053495 — EQUIPMENT SLUSH DRAPE (March 16, 2006)
K011265 — ULTRASOUND TRANSDUCER COVER (October 30, 2001)
K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH (September 18, 2001)
K011422 — SURGICAL DRAPES (July 10, 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)