FDA product code PCY: Investigational Use Only - Microbiology
PCY is the FDA product code for investigational use only - microbiology. It is a Not classified device, reviewed by the Microbiology panel. Devices under PCY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Investigational use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Investigational Use Only - Microbiology |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for PCY devices
openFDA lists no recalls for product code PCY.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code PCY?
PCY is the FDA product code for investigational use only - microbiology. It is a Not classified device, reviewed by the Microbiology panel.
What device class is PCY?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PCY
- Run a recall and safety report across every PCY manufacturer
- Watch product code PCY 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.