510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172985Substantially Equivalent

Ligation Device

Leo Medical Co., Ltd., Changzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172985 is the FDA 510(k) clearance record for Ligation Device, a class II device, cleared for Leo Medical Co., Ltd. on under FDA product code FHN (Ligator, Hemorrhoidal). FDA records list 2 510(k) clearances for Leo Medical Co., Ltd., from to . As of , FDA records show no recalls naming K172985.

Clearance record

Decision date
Received
(260 days to decision)
Product code
FHN Ligator, Hemorrhoidal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Leo Medical Co., Ltd. 2 Floor, 10 Bldg., Changzhou, CN
510(k) summary
Summary PDF
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