FDA product code NBH: Accessories, Arthroscopic

NBH is the FDA product code for accessories, arthroscopic. It is a Class I device, regulated under 21 CFR 888.1100 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under NBH, from 2 different applicants. The average 510(k) review took 56 days (median 56). FDA has posted 55 recalls for NBH devices.

Classification

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

Top NBH applicants

Most recent NBH clearances

Recalls for NBH devices

55 product recalls in 18 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-09-21.

Frequently asked questions

What is FDA product code NBH?

NBH is the FDA product code for accessories, arthroscopic. It is a Class I device, regulated under 21 CFR 888.1100 and reviewed by the Orthopedic panel.

What device class is NBH?

Class I, regulation 21 CFR 888.1100. Typical premarket route: 510(k) exempt.

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

Across 2 cleared submissions the average was 56 days from receipt to decision (median 56).

Which companies have the most NBH clearances?

Utah Medical Products, Inc. (1); Bio-Blitz, Inc. (1).

Have NBH devices been recalled?

Yes: 55 product recalls across 18 recall events; the most recent began 2020-09-21.

Next steps

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