510(k) K963675

THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE by Micro-Medical Devices, Inc. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 27, 1997
Date Received: September 13, 1996
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 Micro-Medical Devices, Inc.

K003695 — MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5 (February 14, 2001)
K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL (March 15, 1999)
K951482 — ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) (September 14, 1995)
K951894 — ACCESS EXPANSION SYSTEM (June 15, 1995)
K945656 — THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE (March 28, 1995)
K940141 — LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH (May 19, 1994)
K936213 — ARTHROSCOPES AND ACCESSORIES (May 18, 1994)

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)