Sterile Plastic Drape
FDA 510(k) K913408 · Acacia Laboratories, Inc.
510(k) numberK913408
Submission
- Device name
- Sterile Plastic Drape
- Applicant
- Acacia Laboratories, Inc.
Santa Ana, CA, US - Received
- July 30, 1991
- Decision date
- March 12, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| 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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| K952419 | Sterigauze Gel DressingMGQ · Traditional | 07/26/1995SE |
| K952420 | Sterigauze Wet DressingKMF · Traditional | 07/12/1995SE |
| K951861 | Stericare Wound Care GelMGQ · Traditional | 07/11/1995SE |
| K952414 | Prefilled Syringe for Inflation of Foley CatheterKNY · Traditional | 06/23/1995SE |
| K951914 | Hydracare Absorbent Wound DressingKMF · Traditional | 05/15/1995SN |
| K950344 | Horizon Foley Catheterization Tray Without CatheterFCM · Traditional | 03/24/1995SEKD |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | 05/07/1990SE |
| K892856 | Newmark(Tm) Coronary Artery Bypass Graft MarkersKRI · Traditional | 11/08/1989SE |
| K892804 | Newchill(Tm) Cardiac InsulatorDWS · Traditional | 07/14/1989SE |
| K884055 | Surgi-Tag(Tm) Sterile Label SetsLYV · Traditional | 10/13/1988SE |
Questions and answers
When was Sterile Plastic Drape cleared by the FDA?
Sterile Plastic Drape (K913408) received a 510(k) decision of Substantially Equivalent on March 12, 1992, 226 days after the submission was received.
What is the product code of K913408?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.