FDA product code QJL: Splint, Intranasal Septal, Cber Led

QJL is the FDA product code for splint, intranasal septal, cber led. It is a Class I device, regulated under 21 CFR 874.4780 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under QJL. The average 510(k) review took 190 days (median 190).

Definition

Splint, Intranasal Septal, CBER led

Classification

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

Top QJL applicants

Most recent QJL clearances

Recalls for QJL devices

openFDA lists no recalls for product code QJL.

Frequently asked questions

What is FDA product code QJL?

QJL is the FDA product code for splint, intranasal septal, cber led. It is a Class I device, regulated under 21 CFR 874.4780 and reviewed by the Ear, Nose and Throat panel.

What device class is QJL?

Class I, regulation 21 CFR 874.4780. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 190 days from receipt to decision (median 190).

Which companies have the most QJL clearances?

Bioinspire Technologies, Incorporated (1).

Next steps

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