N-Pac

Q: When was N-Pac cleared by the FDA?

N-Pac (K923688) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 188 days after the submission was received.

Q: What is the product code of K923688?

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

FDA 510(k) K923688 · National Healthcare Linen Service

Substantially Equivalent

510(k) numberK923688

Submission

Device name: N-Pac
Applicant: National Healthcare Linen Service
Safety Harbor, FL, US
Received: July 23, 1992
Decision date: January 27, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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

510(k)	Device	Decision
K936210	NpacKKX · Traditional	02/03/1994SE
K924055	N-PacFYA · Traditional	08/27/1993SESK
K932003	N-Pac Style C (D-Stat O.R. Protective Gown)FYA · Traditional	06/11/1993SE

Questions and answers

When was N-Pac cleared by the FDA?

N-Pac (K923688) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 188 days after the submission was received.

What is the product code of K923688?

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