ASSERT EO BIOLOGICAL TEST PACK— 510(k) K854631

Substantially Equivalent

Surgicot, Inc.

FDA 510(k) clearance K854631 for ASSERT EO BIOLOGICAL TEST PACK, Substantially Equivalent on 1986-05-27. Applicant: Surgicot, Inc.. Device class: 2.

Clearance details

Applicant: Surgicot, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1985-11-18
Decision date: 1986-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smithtown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRC

K260766 — Celerity 5 HP Biological Indicator (LCB052)2026-04-08
K252680 — Celerity 20 HP Biological Indicator2025-09-24
K251122 — Terragene® Bionova® BT20 Biological Indicator2025-08-04
K251452 — Celerity 5 HP Biological Indicator (LCB052) +3 more2025-06-06
K250044 — Celerity 5 HP Biological Indicator (LCB052) +3 more2025-02-06

More clearances from Surgicot, Inc.

K962605 — PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)1997-03-11
K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER1994-04-13
K863122 — ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.1986-12-17
K855101 — ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR1986-07-17
K854902 — SURGICOT STEAM TEST PACK1986-05-20

Recalls naming K854631

K-number listed on FDA's recall record

Z-0605-2014 — VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.Class II·Terminated·Steris Corporation·20130910

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K854631.

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