FDA product code QWL: Intraoperative Surgical Angle Measurement Tool

QWL is the FDA product code for intraoperative surgical angle measurement tool. It is a Class II device, regulated under 21 CFR 888.4560 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under QWL, 2 in the last five years. The average 510(k) review took 30 days (median 30); 30 days on average over the last three years. 1 De Novo request was granted under it.

Definition

An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.

Classification

510(k) clearances per year for QWL

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

Top QWL applicants

Most recent QWL clearances

Recalls for QWL devices

openFDA lists no recalls for product code QWL.

Frequently asked questions

What is FDA product code QWL?

QWL is the FDA product code for intraoperative surgical angle measurement tool. It is a Class II device, regulated under 21 CFR 888.4560 and reviewed by the Orthopedic panel.

What device class is QWL?

Class II, regulation 21 CFR 888.4560. Typical premarket route: 510(k).

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

Across 2 cleared submissions the average was 30 days from receipt to decision (median 30).

Which companies have the most QWL clearances?

Ruthless, LLC Dba Ruthless Spine (2).

Next steps

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