FDA product code QLH: System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led
QLH is the FDA product code for system, intravaginal, for controlled release of drug substance, cder or cber led. It is a Not classified device, reviewed by the Obstetrics and Gynecology panel. Devices under QLH reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Classification
| Field | Value |
|---|---|
| Device name | System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led |
| Device class | Not classified |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QLH devices
openFDA lists no recalls for product code QLH.
Frequently asked questions
What is FDA product code QLH?
QLH is the FDA product code for system, intravaginal, for controlled release of drug substance, cder or cber led. It is a Not classified device, reviewed by the Obstetrics and Gynecology panel.
What device class is QLH?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLH
- Run a recall and safety report across every QLH manufacturer
- Watch product code QLH 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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