Cleared Traditional

TNI Clear-Guard? 3 angled breathing filter (1545020)

K223258 · Intersurgical , Ltd. · General Hospital

Jun 2023

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K223258 is an FDA 510(k) clearance for the TNI Clear-Guard? 3 angled breathing filter (1545020), a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Intersurgical , Ltd. (Berkshire, GB). The FDA issued a Cleared decision on June 15, 2023, 237 days after receiving the submission on October 21, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number	K223258 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2022
Decision Date	June 15, 2023
Days to Decision	237 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement