Arthrobot(Tm) 75 (190 CM) General Purpose Drape
FDA 510(k) K911520 · Andronic Devices, Ltd.
510(k) numberK911520
Submission
- Device name
- Arthrobot(Tm) 75 (190 CM) General Purpose Drape
- Applicant
- Andronic Devices, Ltd.
Richmond,B.C. V6v-2j2, CA - Received
- April 4, 1991
- Decision date
- August 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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| 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 |
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| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | 02/03/1994SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · Traditional | 10/19/1992SE |
| K922625 | Adept Endoscopic PositionerGAD · Traditional | 10/19/1992SE |
| K911521 | Arthrobot(Tm) 96 (240 CM) Drape with 1 StrapKKX · Traditional | 08/02/1991SE |
Questions and answers
When was Arthrobot(Tm) 75 (190 CM) General Purpose Drape cleared by the FDA?
Arthrobot(Tm) 75 (190 CM) General Purpose Drape (K911520) received a 510(k) decision of Substantially Equivalent on August 2, 1991, 120 days after the submission was received.
What is the product code of K911520?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.