BeneHold Surgical Incise Drape with CHG antimicrobial II— 510(k) K230645

Name: FDA 510(k) clearance K230645
Creator: U.S. Food and Drug Administration
Published: 2023-10-25

Substantially Equivalent

Avery Dennison Medical , Ltd.

FDA 510(k) clearance K230645 for BeneHold Surgical Incise Drape with CHG antimicrobial II, Substantially Equivalent on 2023-10-25. Applicant: Avery Dennison Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Avery Dennison Medical , Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2023-03-08
Decision date: 2023-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longford, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX2015-06-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.