FDA product code LQS: Spermatocele, Alloplastic
LQS is the FDA product code for spermatocele, alloplastic. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under LQS. The average 510(k) review took 68 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Spermatocele, Alloplastic |
| Device class | Unclassified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LQS clearance
Top LQS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mentor Corp. | 1 | 1986-11-19 |
Most recent LQS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863565 | Mentor Corp. | MENTOR ALLOPLASTIC SPERMATOCELE | 1986-11-19 | 68 |
Recalls for LQS devices
openFDA lists no recalls for product code LQS.
Frequently asked questions
What is FDA product code LQS?
LQS is the FDA product code for spermatocele, alloplastic. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.
What device class is LQS?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQS?
Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most LQS clearances?
Mentor Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQS
- Run a recall and safety report across every LQS manufacturer
- Watch product code LQS 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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