FDA 510(k)

BeneHold™ Surgical Incise Drape with CHG antimicrobial II

K-Nummer: K230645 · 2023-10-25

AntragstellerAvery Dennison Medical , Ltd.

Entscheidungsdatum2023-10-25

ProduktcodeKKX

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Medical , Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K230645. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Avery Dennison Medical , Ltd.. The 510(k) number is K230645.

When did BeneHold™ Surgical Incise Drape with CHG antimicrobial II receive FDA 510(k) clearance?

BeneHold™ Surgical Incise Drape with CHG antimicrobial II received FDA 510(k) clearance on 2023-10-25, under 510(k) number K230645.

Who is the listed applicant for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA 510(k) record lists Avery Dennison Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II?

The FDA product code for BeneHold™ Surgical Incise Drape with CHG antimicrobial II is KKX.

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Verwandte Geräte (Code: KKX)

K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.

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