510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K832192Substantially Equivalent

Suction-Hemorrhoid-Ligator

Research Endoscope Systems Intl., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832192 is the FDA 510(k) clearance record for SUCTION-HEMORRHOID-LIGATOR, a class II device, cleared for Research Endoscope Systems Intl. on under FDA product code FHN (Ligator, Hemorrhoidal). FDA records list one 510(k) clearance for Research Endoscope Systems Intl. As of , FDA records show no recalls naming K832192.

Clearance record

Decision date
Received
(172 days to decision)
Product code
FHN Ligator, Hemorrhoidal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Research Endoscope Systems Intl. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FHN

Trailing 12 months

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

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