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510(k) K945656

THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE by Micro-Medical Devices, Inc. — Product Code KKX

K945656 is an FDA 510(k) premarket notification submitted by Micro-Medical Devices, Inc. for the device "THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE". The FDA issued a decision of Substantially Equivalent on March 28, 1995. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Micro-Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1995
Date Received
November 17, 1994
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)
  • K963675 — THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE (January 27, 1997)
  • K951482 — ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) (September 14, 1995)
  • K951894 — ACCESS EXPANSION SYSTEM (June 15, 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)

FDA data resources