Arthrobot(Tm) 96 (240 CM) Drape with 1 Strap
FDA 510(k) K911521 · Andronic Devices, Ltd.
510(k) numberK911521
Submission
- Device name
- Arthrobot(Tm) 96 (240 CM) Drape with 1 Strap
- 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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|---|---|---|---|
| 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 |
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| K935381 | Kaps Positioning ArmFWZ · Traditional | 04/15/1994SE |
| K934124 | Autoquot Automated Aliquotting SystemJQW · Traditional | 04/13/1994SE |
| K936308 | Endex Endoscopic Positioning SystemFQO · Traditional | 03/31/1994SE |
| 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 |
| K911520 | Arthrobot(Tm) 75 (190 CM) General Purpose DrapeKKX · Traditional | 08/02/1991SE |
Questions and answers
When was Arthrobot(Tm) 96 (240 CM) Drape with 1 Strap cleared by the FDA?
Arthrobot(Tm) 96 (240 CM) Drape with 1 Strap (K911521) 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 K911521?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.