Mentor Super Absorbent Drape

FDA 510(k) K973146 · Mentor Ophthalmics, Inc.

Substantially Equivalent

510(k) numberK973146

Submission

Device name
Mentor Super Absorbent Drape
Applicant
Mentor Ophthalmics, Inc.
Santa Barbara, CA, US
Received
August 22, 1997
Decision date
December 4, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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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
K971538Mentor Gemini Hemostatic EraserHQO · Traditional 07/14/1997SE
K964312Mentor Tono-Pen 3HKY · Traditional 11/26/1996SE
K960765Mentor Advent A/B SystemIYO · Traditional 08/08/1996SE

Questions and answers

When was Mentor Super Absorbent Drape cleared by the FDA?

Mentor Super Absorbent Drape (K973146) received a 510(k) decision of Substantially Equivalent on December 4, 1997, 104 days after the submission was received.

What is the product code of K973146?

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