FDA product code MRL: Scale, Sponge, Surgical, Electrically-Powered

MRL is the FDA product code for scale, sponge, surgical, electrically-powered. It is a Class I device, regulated under 21 CFR 880.2740 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under MRL. The average 510(k) review took 131 days (median 131).

Classification

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

Top MRL applicants

Most recent MRL clearances

Recalls for MRL devices

openFDA lists no recalls for product code MRL.

Frequently asked questions

What is FDA product code MRL?

MRL is the FDA product code for scale, sponge, surgical, electrically-powered. It is a Class I device, regulated under 21 CFR 880.2740 and reviewed by the General Hospital panel.

What device class is MRL?

Class I, regulation 21 CFR 880.2740. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 131 days from receipt to decision (median 131).

Which companies have the most MRL clearances?

Surgitrac Corp. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code MRL
• Run a recall and safety report across every MRL manufacturer
• Watch product code MRL 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 General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times