FDA product code MDG: System, Intrafallopian Cannula

MDG is the FDA product code for system, intrafallopian cannula. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under MDG. The average 510(k) review took 249 days (median 249).

Classification

Compare with all 510(k) review times · Search every MDG clearance

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Most recent MDG clearances

Recalls for MDG devices

openFDA lists no recalls for product code MDG.

Frequently asked questions

What is FDA product code MDG?

MDG is the FDA product code for system, intrafallopian cannula. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.

What device class is MDG?

Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).

How long does a 510(k) take for product code MDG?

Across 1 cleared submissions the average was 249 days from receipt to decision (median 249).

Which companies have the most MDG clearances?

Medical Device Technologies, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code MDG
• Run a recall and safety report across every MDG manufacturer
• Watch product code MDG for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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