510(k) Report

FDA applicant

Galenica Enterprises, Inc.

Quebec Canada J7e 4h7, CA5 decisions1984–19941 recall

FDA records 5 decisions for Galenica Enterprises, Inc. (Quebec Canada J7e 4h7, CA) from 1984 to 1994: 5 510(k) clearances. Most are in product codes HGG (Controller, Abortion Unit, Vacuum) and FER (Anoscope And Accessories). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Galenica Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Galenica Enterprises, Inc. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Galenica Enterprises, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Galenica Enterprises, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HGGController, Abortion Unit, Vacuum1decision
  • FERAnoscope And Accessories1decision
  • HIBSpeculum, Vaginal, Nonmetal1decision
  • HICSpeculum, Vaginal, Nonmetal, Fiberoptic1decision
  • GDIDissector, Surgical, General & Plastic Surgery1decision

What has FDA decided for it lately?

  • K923656Lighting Source SystemGalenica Enterprises, Inc. · 1994
  • K896383Disposable External ClampsGalenica Enterprises, Inc. · 1989
  • K883283Disposable AmniotomeGalenica Enterprises, Inc. · 1988
  • K861017Galenica's Disposable AnoscopesGalenica Enterprises, Inc. · 1986
  • K841909Vaginal Speculum - DisposableGalenica Enterprises, Inc. · 19841 recall

All 5 as Galenica Enterprises, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K841909McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior…Apr 13, 2015Class II