I.V. Start Kit & Obstetrical Kit

Q: What is the product code of K843724?

The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.

FDA 510(k) K843724 · E.M. Adams

Substantially Equivalent

510(k) numberK843724

Submission

Device name: I.V. Start Kit & Obstetrical Kit
Applicant: E.M. Adams
Medfield, MA, US
Received: September 24, 1984
Decision date: January 10, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: KKX – Drape, Surgical, Antimicrobial
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4370
Specialty: General, Plastic Surgery

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 510(k)s with product code KKX

510(k)	Device	Applicant	Decision
K230645	BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional	Avery Dennison Medical , Ltd.	10/25/2023SE
K222578	3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional	3M Company	05/18/2023SE
K202208	BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional	Avery Dennison Belgie Bvba	07/30/2021SE
K200238	ControlRad Sterile CoverKKX · Traditional	Controlrad, Inc.	04/26/2020SE
K163556	MediClear PreOpKKX · Traditional	Covalontechnologies, Inc.	09/14/2017SE
K133080	Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional	Foshan Nanhai Plus Medical Co, Ltd.	06/24/2015SE
K141324	Hongyu Disposable Surgical DrapesKKX · Traditional	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	04/14/2015SE
K140195	Surgical DrapeKKX · Traditional	Griffith-Lucas, LLC	09/10/2014SE
K140330	3M Steri-Drape Fabric Surgical DrapesKKX · Traditional	3M Healthcare	08/18/2014SE
K141438	Whitney Medical Solutions EshieldKKX · Traditional	Whitney Medical Solutions	08/14/2014SE

More from Whitney Medical Solutions

510(k)	Device	Decision
K971948	Patient RestraintFMQ · Traditional	08/06/1997SE
K971536	Restraints (Vests and Jackets)FMQ · Traditional	07/01/1997SE
K905173	Splash GuardKYZ · Traditional	04/25/1991SE
K910468	Sterile Disposable Drape(S)FZI · Traditional	03/21/1991SE
K873978	Disposable Bipolar ForcepsGEN · Traditional	11/23/1987SE
K850063	Instrument Pocket · Traditional	02/21/1985SE
K843783	Wet PackEFQ · Traditional	12/19/1984SE
K843782	Dry TrayEFQ · Traditional	12/13/1984SE
K843723	Sterile Instrument Trays-VariousFSM · Traditional	10/23/1984SE
K843115	Sterile Solution BowlKDD · Traditional	09/07/1984SE

Questions and answers

When was I.V. Start Kit & Obstetrical Kit cleared by the FDA?

I.V. Start Kit & Obstetrical Kit (K843724) received a 510(k) decision of Substantially Equivalent on January 10, 1985, 108 days after the submission was received.

What is the product code of K843724?

The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.