FDA product code PCB: External Cerebrospinal Fluid (Csf) Diversion
PCB is the FDA product code for external cerebrospinal fluid (csf) diversion. It is a Class II device, regulated under 21 CFR 882.5560 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under PCB, 1 in the last five years. The average 510(k) review took 105 days (median 105); 105 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 5 recalls for PCB devices, 5 initiated in the last five years.
Definition
Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
Classification
| Field | Value |
|---|---|
| Device name | External Cerebrospinal Fluid (Csf) Diversion |
| Device class | Class II |
| Regulation | 21 CFR 882.5560 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PCB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 105 |
Compare with all 510(k) review times · Search every PCB clearance
Top PCB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Neurosurgery | 1 | 2024-10-24 |
Most recent PCB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242034 | Medtronic Neurosurgery | Duet External Drainage and Monitoring System (EDMS) | 2024-10-24 | 105 |
Recalls for PCB devices
5 product recalls in 1 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-01-22.
| Year | Recalls |
|---|---|
| 2024 | 5 |
Frequently asked questions
What is FDA product code PCB?
PCB is the FDA product code for external cerebrospinal fluid (csf) diversion. It is a Class II device, regulated under 21 CFR 882.5560 and reviewed by the Neurology panel.
What device class is PCB?
Class II, regulation 21 CFR 882.5560. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCB?
Across 1 cleared submissions the average was 105 days from receipt to decision (median 105).
Which companies have the most PCB clearances?
Medtronic Neurosurgery (1).
Have PCB devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2024-01-22.
Next steps
- Run an FDA pathway report with predicate devices for product code PCB
- Run a recall and safety report across every PCB manufacturer
- Watch product code PCB 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times