Celerity 5 HP Biological Indicator (LCB052)— 510(k) K260766

Name: FDA 510(k) clearance K260766
Creator: U.S. Food and Drug Administration
Published: 2026-04-08

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K260766 for Celerity 5 HP Biological Indicator (LCB052), Substantially Equivalent on 2026-04-08. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2026-03-09
Decision date: 2026-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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