FDA product code KGT: Drape, Adhesive, Aerosol

KGT is the FDA product code for drape, adhesive, aerosol. It is a Class I device, regulated under 21 CFR 878.4380 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under KGT. The average 510(k) review took 15 days (median 15). FDA has posted 1 recall for KGT devices.

Classification

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

Top KGT applicants

Most recent KGT clearances

Recalls for KGT devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-03-05.

Frequently asked questions

What is FDA product code KGT?

KGT is the FDA product code for drape, adhesive, aerosol. It is a Class I device, regulated under 21 CFR 878.4380 and reviewed by the General Hospital panel.

What device class is KGT?

Class I, regulation 21 CFR 878.4380. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).

Which companies have the most KGT clearances?

Mowbray Co., Inc. (1).

Have KGT devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2008-03-05.

Next steps

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