FDA product code LZL: Micro-Condom
LZL is the FDA product code for micro-condom. It is a Class III device, regulated under 21 CFR 884.5320 and reviewed by the Obstetrics and Gynecology panel. Devices under LZL reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 9/12/02 per 67 FR 40849 on 6/14/02
Classification
| Field | Value |
|---|---|
| Device name | Micro-Condom |
| Device class | Class III |
| Regulation | 21 CFR 884.5320 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for LZL devices
openFDA lists no recalls for product code LZL.
Frequently asked questions
What is FDA product code LZL?
LZL is the FDA product code for micro-condom. It is a Class III device, regulated under 21 CFR 884.5320 and reviewed by the Obstetrics and Gynecology panel.
What device class is LZL?
Class III, regulation 21 CFR 884.5320. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LZL
- Run a recall and safety report across every LZL manufacturer
- Watch product code LZL 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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