Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model HUCKCR17X27MH, H
FDA 510(k) K094016 · Hinson and Hale Medical Technologies, Inc.
510(k) numberK094016
Submission
- Device name
- Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model HUCKCR17X27MH, H
- Applicant
- Hinson and Hale Medical Technologies, Inc.
Austin, TX, US - Received
- December 29, 2009
- Decision date
- November 19, 2010
- 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
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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 |
More from Whitney Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K102783 | Hinson & Hale Medical Technologies Infused (R) Polyester WrappersFRG · Traditional | 12/22/2010SE |
Questions and answers
When was Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model HUCKCR17X27MH, H cleared by the FDA?
Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model HUCKCR17X27MH, H (K094016) received a 510(k) decision of Substantially Equivalent on November 19, 2010, 325 days after the submission was received.
What is the product code of K094016?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.