510(k) K230645

Device: BeneHold Surgical Incise Drape with CHG antimicrobial II
Applicant: Avery Dennison Medical , Ltd.
510(k) number: K230645
Product code: KKX
Decision: Substantially Equivalent (SESE)
Decision date: 2023-10-25
Date received: 2023-03-08
Regulation: 878.4370
Classification name: Drape, Surgical
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: N

Related Records

Applicant Contact

Contact: Lisa Bartakovics
Address: Ida Business Park, Ballinalee Rd. Longford IE N39 RC80 N39 RC80

FDA Registration Numbers

3019924
9680934
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Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KKX

510(k)	Device	Applicant	Decision date
K222578	3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)	3M Company	2023-05-18
K202208	BeneHold Surgical Incise Drape with CHG antimicrobial	Avery Dennison Belgie Bvba	2021-07-30
K200238	ControlRad Sterile Cover	Controlrad, Inc.	2020-04-26
K163556	MediClear PreOp	Covalontechnologies, Inc.	2017-09-14
K133080	Plus Surgical Drapes (EO Sterilized), PMDB-XXX	Foshan Nanhai Plus Medical Co, Ltd.	2015-06-24
K141324	HONGYU DISPOSABLE SURGICAL DRAPES	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	2015-04-14
K140195	SURGICAL DRAPE	Griffith-Lucas, LLC	2014-09-10
K140330	3M STERI-DRAPE FABRIC SURGICAL DRAPES	3M Healthcare	2014-08-18
K141438	WHITNEY MEDICAL SOLUTIONS ESHIELD	Whitney Medical Solutions	2014-08-14
K140250	3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE	3M Healthcare	2014-07-25
K140064	SURGISLEEVE WOUND PROTECTOR	Covidien	2014-03-12
K131571	AVD RIGHT RADIAL DRAPE	Advanced Vascular Dynamics	2014-01-31
K130404	TIBURON SURGICAL DRAPE	Cardinal Health200, LLC	2013-07-05
K121436	DAS MEDICAL EQUIPMENT DRAPES	Das Medical, LLC	2013-06-06
K121919	SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV	Exact Medical Manufacturing, Inc.	2013-02-14