CK 1600 Series, Towels
FDA 510(k) K872395 · Currie Medical Specialties, Inc.
510(k) numberK872395
Submission
- Device name
- CK 1600 Series, Towels
- Applicant
- Currie Medical Specialties, Inc.
Monrovia, CA, US - Received
- June 22, 1987
- Decision date
- July 2, 1987
- 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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| K151158 | ALP VasQcare Take Home SystemJOW · Traditional | 12/10/2015SE |
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| K140092 | Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes)JOW · Traditional | 04/16/2014SE |
| K112311 | Alp 501 RB Pump SystemJOW · Special | 09/01/2011SE |
| K902441 | Disposable Procedural Trays #Ck-Xxxxx (Various)KDD · Traditional | 08/23/1990SEKD |
| K874760 | CK 4900 Series, Gown and Towel PakLRO · Traditional | 12/10/1987SE |
| K871737 | CK 7000 Series 5 in 1 Connector and Y-ConnectorBZA · Traditional | 06/22/1987SE |
| K864816 | CK 5000 Series, Ace Bandage/Esmark Bandage · Traditional | 01/08/1987SE |
| K864697 | CK 6000 Series, TowelsKKX · Traditional | 12/18/1986SE |
| K834558 | CK10000 Series Pouch & Bags Etc.KCT · Traditional | 09/05/1984SE |
Questions and answers
When was CK 1600 Series, Towels cleared by the FDA?
CK 1600 Series, Towels (K872395) received a 510(k) decision of Substantially Equivalent on July 2, 1987, 10 days after the submission was received.
What is the product code of K872395?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.