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510(k) K913382

MEGA PARACENTESIS KIT by Mega Medical, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1991
Date Received
July 29, 1991
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 Mega Medical, Inc.

  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 1992)
  • K913397 — MEGA ANGIOGRAM KIT (October 31, 1991)
  • K913317 — MEGA ARTHROGRAM KIT (October 31, 1991)
  • K912445 — MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT (October 18, 1991)
  • K912322 — MEGA SPINAL ANESTHESIA KIT (September 26, 1991)
  • K912564 — MEGA PERICARDIOCENTESIS KIT (September 5, 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)