Cleared Traditional

BeneHold? Surgical Incise Drape with CHG antimicrobial II

K230645 · Avery Dennison Medical , Ltd. · General Hospital

Oct 2023

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K230645 is an FDA 510(k) clearance for the BeneHold? Surgical Incise Drape with CHG antimicrobial II, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Avery Dennison Medical , Ltd. (Longford, IE). The FDA issued a Cleared decision on October 25, 2023, 231 days after receiving the submission on March 8, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K230645 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2023
Decision Date	October 25, 2023
Days to Decision	231 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement