Data / Medical devices / Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device (FAP): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Cystometric Gas (Carbon-Dioxide) On Hydraulic Device (product code FAP, Class 2, 21 CFR 876.1620). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 85 510(k) clearances under this code, the latest on December 13, 2012, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FAP
- Device class
- 2
- Regulation
- 876.1620
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| France | 1 |
| Italy | 1 |
Makers of Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
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 |
|---|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 4 | May 17, 1985 | 0 | 0 | 0 | api.fda.gov |
| Prince Medical SAS | ERCUIS Oise, France | Manufacturer | 2 | February 5, 1993 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | February 19, 1992 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | February 19, 1992 | 0 | 0 | 0 | api.fda.gov |
| Neurovision Medical Products, Inc. | Ventura, CA, United States | Manufacturer | 1 | December 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Spes Medica S.P.A | Genova Liguria, Italy | Exporter to the US, Manufacturer | 1 | December 13, 2012 | 0 | 1 | 0 | api.fda.gov |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 13, 2012. 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.