Customed Basic Pack II
FDA 510(k) K902885 · Customed, Inc.
510(k) numberK902885
Submission
- Device name
- Customed Basic Pack II
- Applicant
- Customed, Inc.
Carolina Puerto Rico, US - Received
- July 2, 1990
- Decision date
- September 19, 1990
- 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.
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 |
More from Whitney Medical Solutions
| 510(k) | Device | Decision |
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| K260116 | CustoMED ViewerLLZ · Traditional | 06/03/2026SE |
| K974647 | Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633KKX · Traditional | 01/05/1998SE |
| K971920 | Gown Poly Reinforced Large(Product NO.900-522)/(REORDER No. 0522)FYA · Traditional | 12/04/1997SE |
| K964011 | Suction Catheter Tray Product No. 900277LRO · Traditional | 11/25/1996SESK |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | 10/04/1996SE |
| K962596 | Customed Blood Extraction KitGJE · Traditional | 09/27/1996SE |
| K961442 | Universal Drainage TrayFCM · Traditional | 05/09/1996SE |
| K953678 | Sterimed Sterization Wrapper (Non-Sterile)FRG · Traditional | 10/02/1995SE |
| K950295 | Wound Closure/Laceration TrayLRO · Traditional | 04/18/1995SE |
| K942177 | Foley Catheterization TrayFCM · Traditional | 09/08/1994SE |
Questions and answers
When was Customed Basic Pack II cleared by the FDA?
Customed Basic Pack II (K902885) received a 510(k) decision of Substantially Equivalent on September 19, 1990, 79 days after the submission was received.
What is the product code of K902885?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.