510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781918Substantially Equivalent

Irrigator, Body Cavity

Bci, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781918 is the FDA 510(k) clearance record for IRRIGATOR, BODY CAVITY, a class II device, cleared for Bci, Inc. on under FDA product code EYN (Tray, Irrigation, Sterile). FDA records list one 510(k) clearance for Bci, Inc. As of , FDA records show no recalls naming K781918.

Clearance record

Decision date
Received
(94 days to decision)
Product code
EYN Tray, Irrigation, Sterile
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bci, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EYN

Trailing 12 months

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

FDA records show no clearances under product code EYN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EYN, 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