FDA product code LNL: Stimulator, Electrical For Sperm Collection

LNL is the FDA product code for stimulator, electrical for sperm collection. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under LNL. The average 510(k) review took 455 days (median 455).

Classification

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

Top LNL applicants

Most recent LNL clearances

Recalls for LNL devices

openFDA lists no recalls for product code LNL.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month

Frequently asked questions

What is FDA product code LNL?

LNL is the FDA product code for stimulator, electrical for sperm collection. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.

What device class is LNL?

Unclassified. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 455 days from receipt to decision (median 455).

Which companies have the most LNL clearances?

National Rehab Hospital (1).

Next steps

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