Absorbable Gauze Drape
FDA 510(k) K901465 · Ulti-Med Intl., Inc.
510(k) numberK901465
Submission
- Device name
- Absorbable Gauze Drape
- Applicant
- Ulti-Med Intl., Inc.
Glendale Hts., IL, US - Received
- March 27, 1990
- Decision date
- June 12, 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 |
|---|---|---|
| K103011 | Ulticare Safety Insulin SyringeMEG · Traditional | 02/02/2011SE |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | 06/17/1993SE |
| K923175 | Surgical Instrument Kit, DisposableFMC · Traditional | 06/17/1993SE |
| K920989 | Surgical Instrument Kit, DisposableKDD · Traditional | 10/19/1992SEKD |
| K922828 | Ulcer Wound TrayKKX · Traditional | 09/28/1992SEKD |
| K914244 | Sterile Custom Surgical KitsKDD · Traditional | 02/24/1992SEKD |
| K914431 | Absorbent FiberNAB · Traditional | 12/04/1991SE |
| K912693 | Post Operative SpongeNAB · Traditional | 10/04/1991SE |
| K912692 | Conforming BandageNAB · Traditional | 10/04/1991SE |
| K904896 | Eye PadHMP · Traditional | 12/05/1990SE |
Questions and answers
When was Absorbable Gauze Drape cleared by the FDA?
Absorbable Gauze Drape (K901465) received a 510(k) decision of Substantially Equivalent on June 12, 1990, 77 days after the submission was received.
What is the product code of K901465?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.