FDA product code PEW: Implantable Transprostatic Tissue Retractor System
PEW is the FDA product code for implantable transprostatic tissue retractor system. It is a Class II device, regulated under 21 CFR 876.5530 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under PEW, 1 in the last five years. The average 510(k) review took 50 days (median 30). 1 De Novo request was granted under it. FDA has posted 2 recalls for PEW devices, 1 initiated in the last five years.
Definition
The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Classification
| Field | Value |
|---|---|
| Device name | Implantable Transprostatic Tissue Retractor System |
| Device class | Class II |
| Regulation | 21 CFR 876.5530 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PEW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 52 |
| 2019 | 2 | 27 |
| 2020 | 2 | 66 |
| 2023 | 1 | 30 |
Compare with all 510(k) review times · Search every PEW clearance
Top PEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neotract, Inc. | 10 | 2023-09-22 |
Most recent PEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232558 | Neotract, Inc. | UroLift 2 ATC Advanced Tissue Control System | 2023-09-22 | 30 |
| K201837 | Neotract, Inc. | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | 2020-07-31 | 29 |
| K200441 | Neotract, Inc. | UroLift Advanced Tissue Control (ATC) System | 2020-06-05 | 102 |
| K193269 | Neotract, Inc. | UroLift System (UL400) | 2019-12-20 | 24 |
| K190377 | Neotract, Inc. | UroLift System UL400 | 2019-03-21 | 30 |
Recalls for PEW devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-06-24.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4648 — Tissue marker, implantable, any type, each
Frequently asked questions
What is FDA product code PEW?
PEW is the FDA product code for implantable transprostatic tissue retractor system. It is a Class II device, regulated under 21 CFR 876.5530 and reviewed by the Gastroenterology and Urology panel.
What device class is PEW?
Class II, regulation 21 CFR 876.5530. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEW?
Across 10 cleared submissions the average was 50 days from receipt to decision (median 30).
Which companies have the most PEW clearances?
Neotract, Inc. (10).
Have PEW devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code PEW
- Run a recall and safety report across every PEW manufacturer
- Watch product code PEW 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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