FDA product code MQW: Transilluminator, Fiber Optic

MQW is the FDA product code for transilluminator, fiber optic. It is a Class I device, regulated under 21 CFR 874.4350 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under MQW. The average 510(k) review took 42 days (median 42).

Classification

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

Top MQW applicants

Most recent MQW clearances

Recalls for MQW devices

openFDA lists no recalls for product code MQW.

Frequently asked questions

What is FDA product code MQW?

MQW is the FDA product code for transilluminator, fiber optic. It is a Class I device, regulated under 21 CFR 874.4350 and reviewed by the Ear, Nose and Throat panel.

What device class is MQW?

Class I, regulation 21 CFR 874.4350. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 42 days from receipt to decision (median 42).

Which companies have the most MQW clearances?

KARL STORZ Endoscopy-America, Inc. (1).

Next steps

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