FDA product code MGO: Closure, Wound, Adhesive

MGO is the FDA product code for closure, wound, adhesive. It is a Class I device, regulated under 21 CFR 878.4018 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under MGO. The average 510(k) review took 120 days (median 120). FDA has posted 9 recalls for MGO devices.

Classification

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

Top MGO applicants

Most recent MGO clearances

Recalls for MGO devices

9 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-07-26.

Frequently asked questions

What is FDA product code MGO?

MGO is the FDA product code for closure, wound, adhesive. It is a Class I device, regulated under 21 CFR 878.4018 and reviewed by the General and Plastic Surgery panel.

What device class is MGO?

Class I, regulation 21 CFR 878.4018. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 120 days from receipt to decision (median 120).

Which companies have the most MGO clearances?

Deroyal Industries, Inc. (1).

Have MGO devices been recalled?

Yes: 9 product recalls across 1 recall events; the most recent began 2013-07-26.

Next steps

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