FDA product code HGD: Applicator, Vaginal

HGD is the FDA product code for applicator, vaginal. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HGD. The average 510(k) review took 50 days (median 50). FDA has posted 2 recalls for HGD devices, 1 initiated in the last five years.

Classification

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

Top HGD applicants

Most recent HGD clearances

Recalls for HGD devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-08.

Frequently asked questions

What is FDA product code HGD?

HGD is the FDA product code for applicator, vaginal. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.

What device class is HGD?

Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 50 days from receipt to decision (median 50).

Which companies have the most HGD clearances?

Kline Technologies, Ltd. (1).

Have HGD devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2024-04-08.

Next steps

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