FDA product code PCU: Pancreatic Stent, Covered, Metallic, Removable
PCU is the FDA product code for pancreatic stent, covered, metallic, removable. It is a Class II device, regulated under 21 CFR 876.5015 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under PCU, 2 in the last five years, from 4 different applicants. The average 510(k) review took 125 days (median 114); 204 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 6 recalls for PCU devices.
Definition
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Classification
| Field | Value |
|---|---|
| Device name | Pancreatic Stent, Covered, Metallic, Removable |
| Device class | Class II |
| Regulation | 21 CFR 876.5015 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PCU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 89 |
| 2019 | 2 | 139 |
| 2021 | 1 | 178 |
| 2022 | 1 | 237 |
| 2026 | 1 | 204 |
Compare with all 510(k) review times · Search every PCU clearance
Top PCU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corporation | 7 | 2022-09-07 |
| Taewoong Medical Co., Ltd. | 1 | 2026-03-13 |
| Boston Scientific Corp | 1 | 2015-08-05 |
| Xlumena, Inc. | 1 | 2014-04-23 |
Most recent PCU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252648 | Taewoong Medical Co., Ltd. | Niti-S SPAXUS Stent | 2026-03-13 | 204 |
| K220112 | Boston Scientific Corporation | AXIOS Stent and Electrocautery-Enhanced Delivery System | 2022-09-07 | 237 |
| K203132 | Boston Scientific Corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | 2021-04-15 | 178 |
| K192043 | Boston Scientific Corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | 2019-08-26 | 26 |
| K181905 | Boston Scientific Corporation | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | 2019-03-25 | 252 |
Recalls for PCU devices
6 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-12-01.
| Year | Recalls |
|---|---|
| 2020 | 6 |
Frequently asked questions
What is FDA product code PCU?
PCU is the FDA product code for pancreatic stent, covered, metallic, removable. It is a Class II device, regulated under 21 CFR 876.5015 and reviewed by the Gastroenterology and Urology panel.
What device class is PCU?
Class II, regulation 21 CFR 876.5015. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCU?
Across 10 cleared submissions the average was 125 days from receipt to decision (median 114).
Which companies have the most PCU clearances?
Boston Scientific Corporation (7); Taewoong Medical Co., Ltd. (1); Boston Scientific Corp (1); Xlumena, Inc. (1).
Have PCU devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2020-12-01.
Next steps
- Run an FDA pathway report with predicate devices for product code PCU
- Run a recall and safety report across every PCU manufacturer
- Watch product code PCU 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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