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510(k) K897120

EQUIP COVERS, STERILE by Amedic USA — Product Code KKX

K897120 is an FDA 510(k) premarket notification submitted by Amedic USA for the device "EQUIP COVERS, STERILE". The FDA issued a decision of Substantially Equivalent on January 4, 1990. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Amedic USA has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
December 26, 1989
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 Amedic USA

  • K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE (September 5, 1989)
  • K892069 — EXTENDED COVERS, STERILE (August 8, 1989)
  • K892071 — GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE (August 8, 1989)
  • K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE (August 4, 1989)
  • K871467 — BIOPSY NEEDLE GUIDE KIT, STERILE (August 21, 1987)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K871609 — ULTRASOUND TRANSDUCER SHEATHS, STERILE (July 15, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K864219 — TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE (March 27, 1987)

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