BeneHold Surgical Incise Drape with CHG antimicrobial
FDA 510(k) clearance K202208 · decided 2021-07-30
Clearance details
- K-number
- K202208
- Device name
- BeneHold Surgical Incise Drape with CHG antimicrobial
- Applicant
- Avery Dennison Belgie Bvba
- Decision
- Substantially Equivalent
- Date received
- 2020-08-06
- Decision date
- 2021-07-30
- Days to decision
- 358 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Turnhout, BE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645) | Avery Dennison Medical , Ltd. | 2023-10-25 |
| 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (K222578) | 3M Company | 2023-05-18 |
| ControlRad Sterile Cover (K200238) | Controlrad, Inc. | 2020-04-26 |
| MediClear PreOp (K163556) | Covalontechnologies, Inc. | 2017-09-14 |
| Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080) | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 |
| HONGYU DISPOSABLE SURGICAL DRAPES (K141324) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 |
| SURGICAL DRAPE (K140195) | Griffith-Lucas, LLC | 2014-09-10 |
| 3M STERI-DRAPE FABRIC SURGICAL DRAPES (K140330) | 3M Healthcare | 2014-08-18 |
| WHITNEY MEDICAL SOLUTIONS ESHIELD (K141438) | Whitney Medical Solutions | 2014-08-14 |
| 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (K140250) | 3M Healthcare | 2014-07-25 |
| SURGISLEEVE WOUND PROTECTOR (K140064) | Covidien | 2014-03-12 |
| AVD RIGHT RADIAL DRAPE (K131571) | Advanced Vascular Dynamics | 2014-01-31 |
Recalls involving this device
No recalls on record reference this clearance.