510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854631Substantially Equivalent

Assert Eo Biological Test Pack

Surgicot, Inc., Smithtown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854631 is the FDA 510(k) clearance record for ASSERT EO BIOLOGICAL TEST PACK, a class II device, cleared for Surgicot, Inc. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 19 510(k) clearances for Surgicot, Inc., from to . As of , FDA records show one recall naming K854631.

Clearance record

Decision date
Received
(190 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Surgicot, Inc. 55 Kennedy Dr., Smithtown NY
Third party review
No

Clearances, product code FRC

Trailing 12 months
1 clearance under product code FRC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260