Sri LP Drape

FDA 510(k) K080796 · Sri/Surgical Express

Substantially Equivalent

510(k) numberK080796

Submission

Device name
Sri LP Drape
Applicant
Sri/Surgical Express
Austin, TX, US
Received
March 20, 2008
Decision date
November 17, 2008
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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)DeviceApplicantDecision
K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional Avery Dennison Medical , Ltd.10/25/2023SE
K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional 3M Company05/18/2023SE
K202208BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional Avery Dennison Belgie Bvba07/30/2021SE
K200238ControlRad Sterile CoverKKX · Traditional Controlrad, Inc.04/26/2020SE
K163556MediClear PreOpKKX · Traditional Covalontechnologies, Inc.09/14/2017SE
K133080Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional Foshan Nanhai Plus Medical Co, Ltd.06/24/2015SE
K141324Hongyu Disposable Surgical DrapesKKX · Traditional Weihai Hongyu Nonwoven Fabric Products Co., Ltd.04/14/2015SE
K140195Surgical DrapeKKX · Traditional Griffith-Lucas, LLC09/10/2014SE
K1403303M Steri-Drape Fabric Surgical DrapesKKX · Traditional 3M Healthcare08/18/2014SE
K141438Whitney Medical Solutions EshieldKKX · Traditional Whitney Medical Solutions08/14/2014SE

More from Whitney Medical Solutions

510(k)DeviceDecision
K080723Sri LP GownFYA · Abbreviated 11/13/2008SE
K080707Sri PLR GownFYA · Abbreviated 11/13/2008SE
K023635Sri/Surgical Express SP Reusable Surgical GownFYA · Traditional 11/18/2002SE

Questions and answers

When was Sri LP Drape cleared by the FDA?

Sri LP Drape (K080796) received a 510(k) decision of Substantially Equivalent on November 17, 2008, 242 days after the submission was received.

What is the product code of K080796?

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