Sup 5415 Single Use Only Sterile Hospital Kit
FDA 510(k) K923283 · Savoy Medical Supply Co., Inc.
510(k) numberK923283
Submission
- Device name
- Sup 5415 Single Use Only Sterile Hospital Kit
- Applicant
- Savoy Medical Supply Co., Inc.
Hauppauge, NY, US - Received
- July 6, 1992
- Decision date
- January 4, 1993
- Decision
- Unknown (SESK)
- 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 |
More from Whitney Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K922133 | Hospital Kit SV 105LRO · Traditional | 06/07/1993SESK |
| K922130 | Hospital Kit DK 117MDM · Traditional | 05/24/1993SEKD |
| K922127 | Hospital Kit GP 103MDM · Traditional | 03/29/1993SESD |
| K923281 | SV 100200 - Single Use Only - Sterile Hospital KitMDM · Traditional | 03/26/1993SE |
| K922128 | Hospital Kit Ep 104MDM · Traditional | 03/23/1993SESK |
| K922126 | Hospital Kit ENT 1125LRP · Traditional | 01/21/1993SE |
Questions and answers
When was Sup 5415 Single Use Only Sterile Hospital Kit cleared by the FDA?
Sup 5415 Single Use Only Sterile Hospital Kit (K923283) received a 510(k) decision of Unknown on January 4, 1993, 182 days after the submission was received.
What is the product code of K923283?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.