HEMORPEX SYSTEM— 510(k) K090432

Substantially Equivalent

Angiologica B. M. Srl

FDA 510(k) clearance K090432 for HEMORPEX SYSTEM, Substantially Equivalent on 2009-05-29. Applicant: Angiologica B. M. Srl. Device class: 2.

Clearance details

Applicant: Angiologica B. M. Srl
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-02-19
Decision date: 2009-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Martino Siccomario, Pavia, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code FER

K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)2025-10-09
K242668 — Gastro Concepts Air Assist2024-12-13
K230439 — WellCare Anoscope2023-12-22
K200021 — Applied Medical Anoscope2021-01-06
K171701 — GelPOINT Path Transanal Access Platform2017-07-20

More clearances from Angiologica B. M. Srl

K043191 — REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH2005-05-16

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