VERIFY 270FP CHALLENGE PACK— 510(k) K103053

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K103053 for VERIFY 270FP CHALLENGE PACK, Substantially Equivalent on 2011-03-10. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2010-10-15
Decision date: 2011-03-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from STERIS Corporation

Recalls naming K103053

K-number listed on FDA's recall record

Z-1166-2014 — VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.Class II·Terminated·Steris Corporation·20131219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103053.

Data sourced from openFDA. This site is unofficial and independent of the FDA.