FDA product code NBZ: Clamp And Cutter, Umbilical

NBZ is the FDA product code for clamp and cutter, umbilical. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under NBZ. The average 510(k) review took 313 days (median 313).

Classification

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

Top NBZ applicants

Most recent NBZ clearances

Recalls for NBZ devices

openFDA lists no recalls for product code NBZ.

Frequently asked questions

What is FDA product code NBZ?

NBZ is the FDA product code for clamp and cutter, umbilical. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.

What device class is NBZ?

Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 313 days from receipt to decision (median 313).

Which companies have the most NBZ clearances?

Ningbo Feite Medical Device Co., Ltd. (1).

Next steps

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

All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times