Data / Medical devices / Prostate Immobilizer Rectal Balloon
Prostate Immobilizer Rectal Balloon (PCT): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Prostate Immobilizer Rectal Balloon (product code PCT, Class 2, 21 CFR 892.5720). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on February 10, 2023, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- PCT
- Device class
- 2
- Regulation
- 892.5720
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Netherlands | 1 |
| Costa Rica | 1 |
| Colombia | 1 |
| China | 1 |
Makers of Prostate Immobilizer Rectal Balloon
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 1 | January 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| DXTX Medical Inc. | Pittsburgh, PA, United States | Manufacturer | 1 | February 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Myriad Medical LLC | Tampa, FL, United States | Specification developer | 1 | March 31, 2015 | 0 | 0 | 0 | api.fda.gov |
| Qlrad | Almere Flevoland, Netherlands | Manufacturer | 1 | November 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Cartago | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caribbean Manufacturing SAS | Cartagena Bolivar, Colombia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koo (Shanghai) Industries Co., Ltd | Songjiang Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.