Sta-Put Non-Magnetic Instrument Drape Catalog #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/Dexter Wrap

FDA 510(k) K950830 · Avail-Southwest Division

Substantially Equivalent

510(k) numberK950830

Submission

Device name
Sta-Put Non-Magnetic Instrument Drape Catalog #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/Dexter Wrap
Applicant
Avail-Southwest Division
Dallas, TX, US
Received
February 24, 1995
Decision date
May 3, 1995
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.

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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

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K933520Endoscopic Anti-Fog Kit, 100-302-00GCJ · Traditional 08/24/1993SE
K864158ThermapadKME · Traditional 03/02/1987SE

Questions and answers

When was Sta-Put Non-Magnetic Instrument Drape Catalog #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/Dexter Wrap cleared by the FDA?

Sta-Put Non-Magnetic Instrument Drape Catalog #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/Dexter Wrap (K950830) received a 510(k) decision of Substantially Equivalent on May 3, 1995, 68 days after the submission was received.

What is the product code of K950830?

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