510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900086Substantially Equivalent

Hemorrhoidal Ligator with Suction

Baxter Healthcare Corporation, Niles IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900086 is the FDA 510(k) clearance record for HEMORRHOIDAL LIGATOR WITH SUCTION, a class II device, cleared for Baxter Healthcare Corp on under FDA product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K900086.

Clearance record

Decision date
Received
(74 days to decision)
Product code
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 7280 N. Caldwell, Niles IL
Third party review
No

Clearances, product code KDH

Trailing 12 months

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

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