HAEMOBAND MULTI-LIGATOR— 510(k) K091519

Name: FDA 510(k) clearance K091519
Creator: U.S. Food and Drug Administration
Published: 2009-07-28

Substantially Equivalent

Haemoband Surgical, Ltd.

FDA 510(k) clearance K091519 for HAEMOBAND MULTI-LIGATOR, Substantially Equivalent on 2009-07-28. Applicant: Haemoband Surgical, Ltd.. Device class: 2.

Clearance details

Applicant: Haemoband Surgical, Ltd.
Product code: Code FHN
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2009-05-22
Decision date: 2009-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHN

view all

K213223 — Multi-Band Ligator2022-06-06
K172985 — Ligation Device2018-06-14
K150718 — Wi-3 HAL-RAR System2015-06-12
K131282 — NEXUS HEMORRHOID LIGATOR2013-07-11
K093497 — THD BANDY2010-07-15

More clearances from Haemoband Surgical, Ltd.

view all

K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)2025-10-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.