FDA product code HNX: Depressor, Orbital

HNX is the FDA product code for depressor, orbital. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HNX. The average 510(k) review took 28 days (median 28).

Classification

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

Top HNX applicants

Most recent HNX clearances

Recalls for HNX devices

openFDA lists no recalls for product code HNX.

Frequently asked questions

What is FDA product code HNX?

HNX is the FDA product code for depressor, orbital. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.

What device class is HNX?

Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.

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

Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).

Which companies have the most HNX clearances?

Future Medical Systems, Inc. (2).

Next steps

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