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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 the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Belgie Bvba. It received FDA 510(k) clearance on 2021-07-30 under 510(k) 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. The listed applicant is Avery Dennison Belgie Bvba. The 510(k) number is K202208.

When did BeneHold Surgical Incise Drape with CHG antimicrobial receive FDA 510(k) clearance?

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

Who is the listed applicant for BeneHold Surgical Incise Drape with CHG antimicrobial?

The FDA 510(k) record lists Avery Dennison Belgie Bvba as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07356323A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic SurgeryRECRUITING

Other records listing Avery Dennison Belgie Bvba as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170407BD ChloraShield IV Dressing with CHG Antimicrobial

Related Devices (Code: KKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.

Official Source

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

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