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FDA 510(k)

BeneHold Surgical Incise Drape with CHG antimicrobial

K-Number: K202208 · 2021-07-30

ApplicantAvery Dennison Belgie Bvba
Decision Date2021-07-30
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BeneHold Surgical Incise Drape with CHG antimicrobial is a medical device manufactured by Avery Dennison Belgie Bvba. It received FDA 510(k) clearance on 2021-07-30 under approval number K202208. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BeneHold Surgical Incise Drape with CHG antimicrobial?

BeneHold Surgical Incise Drape with CHG antimicrobial is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Avery Dennison Belgie Bvba. The 510(k) number is K202208.

When was BeneHold Surgical Incise Drape with CHG antimicrobial approved by the FDA?

BeneHold Surgical Incise Drape with CHG antimicrobial received FDA 510(k) clearance on 2021-07-30, under approval number K202208.

What company makes BeneHold Surgical Incise Drape with CHG antimicrobial?

BeneHold Surgical Incise Drape with CHG antimicrobial is manufactured by Avery Dennison Belgie Bvba.

What is the FDA product code for BeneHold Surgical Incise Drape with CHG antimicrobial?

The FDA product code for BeneHold Surgical Incise Drape with CHG antimicrobial is KKX.

Related Clinical Trials

NCT07604636 Adjunctive Ozone Therapy for Residual Periodontal Pockets COMPLETED NCT05741866 Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) COMPLETED NCT07189858 Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada COMPLETED NCT06717308 Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications. RECRUITING NCT07551297 Ozone Therapy After Open Flap Debridement in Periodontitis COMPLETED NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

Other Devices by Avery Dennison Belgie Bvba

K170407BD ChloraShield IV Dressing with CHG Antimicrobial

Related Devices (Code: KKX)

K163556MediClear PreOpCovalontechnologies, Inc. K200238ControlRad Sterile CoverControlrad, Inc. K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd. K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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