510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832040Substantially Equivalent

Sterile Fluid Producing Unit #Ep550

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

K832040 is the FDA 510(k) clearance record for STERILE FLUID PRODUCING UNIT #EP550, a class II device, cleared for American Cystocope Makers, Inc. on under FDA product code LJH (System, Irrigation, Urological). FDA records list 9 510(k) clearances for American Cystocope Makers, Inc., from to . As of , FDA records show no recalls naming K832040.

Clearance record

Decision date
Received
(97 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Cystocope Makers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LJH

Trailing 12 months
1 clearance under product code LJH in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJH, 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 20261
October 20260