Promepal Sam
MC Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
RocaTub Ureteral Catheter Ref K192183
What Promepal Sam makes
Promepal Sam makes the RocaTub Ureteral Catheter, a device used for urinary tract access and drainage.
The RocaTub Ureteral Catheter is a Class II medical device listed in the FDA 510(k) registry, and the company is based in the United States.
Frequently asked questions
What does Promepal Sam make?
Promepal Sam makes the RocaTub Ureteral Catheter, which is used for urinary tract access and drainage. This is the only device explicitly mentioned in the provided data, and no other products are listed or implied.
Where is Promepal Sam based?
Promepal Sam is based in the United States, as stated in the COUNTRY field of the device data. No further details about the company's location within the US are provided.
Which regulatory registry lists Promepal Sam's devices?
Promepal Sam's devices are listed in the FDA 510(k) registry, as indicated in the LISTED IN field. This registry contains information about medical devices that have undergone premarket notification under Section 510(k) of the FD&C Act.
How are Promepal Sam's devices classified?
Promepal Sam's devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field. This classification indicates moderate to high risk and typically requires special controls to ensure safety and effectiveness.
Information
- Country
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