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510(k) K172985

Ligation Device by Leo Medical Co., Ltd. — Product Code FHN

K172985 is an FDA 510(k) premarket notification submitted by Leo Medical Co., Ltd. for the device "Ligation Device". The FDA issued a decision of Substantially Equivalent on June 14, 2018. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Leo Medical Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2018
Date Received
September 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Hemorrhoidal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

Other clearances by Leo Medical Co., Ltd.

  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)

Other clearances for product code FHN

  • K213223 — Multi-Band Ligator (June 6, 2022)
  • K150718 — Wi-3 HAL-RAR System (June 12, 2015)
  • K131282 — NEXUS HEMORRHOID LIGATOR (July 11, 2013)
  • K093497 — THD BANDY (July 15, 2010)
  • K091519 — HAEMOBAND MULTI-LIGATOR (July 28, 2009)
  • K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (September 26, 2007)
  • K020824 — SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 (April 12, 2002)
  • K020526 — MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR (March 19, 2002)
  • K001236 — RIZA BAND STRETCHER (RBS)-60000 (July 17, 2000)
  • K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE (April 24, 2000)

FDA data resources