510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811397Substantially Equivalent

Eca

Gillco, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811397 is the FDA 510(k) clearance record for ECA, a class I device, cleared for Gillco, Inc. on under FDA product code FOA (Board, Cardiopulmonary). FDA records list one 510(k) clearance for Gillco, Inc. As of , FDA records show no recalls naming K811397.

Clearance record

Decision date
Received
(45 days to decision)
Product code
FOA Board, Cardiopulmonary
Regulation
21 CFR 880.6080
Device class
Class I
Review panel
General Hospital
Applicant
Gillco, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FOA

Trailing 12 months

FDA records hold no clearances under product code FOA in the trailing twelve months.

FDA records show no clearances under product code FOA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FOA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260