BeneHold Surgical Incise Drape with CHG antimicrobial— 510(k) K202208

Name: FDA 510(k) clearance K202208
Creator: U.S. Food and Drug Administration
Published: 2021-07-30

Substantially Equivalent

Avery Dennison Belgie Bvba

FDA 510(k) clearance K202208 for BeneHold Surgical Incise Drape with CHG antimicrobial, Substantially Equivalent on 2021-07-30. Applicant: Avery Dennison Belgie Bvba. Device class: 2.

Clearance details

Applicant: Avery Dennison Belgie Bvba
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2020-08-06
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Turnhout, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

view all

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX2015-06-24

More clearances from Avery Dennison Belgie Bvba

view all

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