Cleared Traditional

BeneHold Surgical Incise Drape with CHG antimicrobial

K202208 · Avery Dennison Belgie Bvba · General Hospital
Jul 2021
Decision
358d
Days
Class 2
Risk

About This 510(k) Submission

K202208 is an FDA 510(k) clearance for the BeneHold Surgical Incise Drape with CHG antimicrobial, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on July 30, 2021, 358 days after receiving the submission on August 6, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K202208 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2020
Decision Date July 30, 2021
Days to Decision 358 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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