The Flat Panel Steirle Drape System(Tm), Video Monitor Sterile Drape
FDA 510(k) K963675 · Micro-Medical Devices, Inc.
510(k) numberK963675
Submission
- Device name
- The Flat Panel Steirle Drape System(Tm), Video Monitor Sterile Drape
- Applicant
- Micro-Medical Devices, Inc.
Castle Pines Village, CO, US - Received
- September 13, 1996
- Decision date
- January 27, 1997
- 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
| 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 |
|---|---|---|
| K003695 | Microscope-Stainless Steel/Fiber Optic: .5-2.6MM Model MMD 4500 Series and 2.7-5.0MM…HRX · Traditional | 02/14/2001SE |
| K983882 | Micro Endoscope-Stainless Steel, Model MMD-1300, Micro Endoscope-Polyimide,Model MMD-1400HXR · Traditional | 03/15/1999SE |
| K951482 | Endoscopes, Fiber Optic Laparoscopes, (Sterilizable)GCJ · Traditional | 09/14/1995SE |
| K951894 | Access Expansion SystemFHO · Traditional | 06/15/1995SESK |
| K945656 | The Coupler/Drape(Tm), Video Camera Sterile DrapeKKX · Traditional | 03/28/1995SE |
| K940141 | Laparaoscopes Electronic with Sterile SheathGCJ · Traditional | 05/19/1994SE |
| K936213 | Arthroscopes and AccessoriesHRX · Traditional | 05/18/1994SE |
Questions and answers
When was The Flat Panel Steirle Drape System(Tm), Video Monitor Sterile Drape cleared by the FDA?
The Flat Panel Steirle Drape System(Tm), Video Monitor Sterile Drape (K963675) received a 510(k) decision of Substantially Equivalent on January 27, 1997, 136 days after the submission was received.
What is the product code of K963675?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.