GALENICA'S DISPOSABLE ANOSCOPES— 510(k) K861017

Name: FDA 510(k) clearance K861017
Creator: U.S. Food and Drug Administration
Published: 1986-06-13

Substantially Equivalent

Galenica Enterprises, Inc.

FDA 510(k) clearance K861017 for GALENICA'S DISPOSABLE ANOSCOPES, Substantially Equivalent on 1986-06-13. Applicant: Galenica Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Galenica Enterprises, Inc.
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1986-03-18
Decision date: 1986-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec Canada J7e 4h7, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code FER

view all

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 Galenica Enterprises, Inc.

view all

K923656 — LIGHTING SOURCE SYSTEM1994-09-08
K896383 — DISPOSABLE EXTERNAL CLAMPS1989-12-06
K883283 — DISPOSABLE AMNIOTOME1988-10-18
K841909 — VAGINAL SPECULUM - DISPOSABLE1984-07-31

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