Skip to content
Product safetyFDAUnited StatesImports

Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device

10 September 2026

In plain English

FDA is classifying the implanted tibial electrical urinary continence device into class II, subject to identified special controls.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
10 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and
The full text is at the source

Olive tells you which of these hit your products.

Olive reads every change like these against your own products, codes and trade lanes, whether you import, export or both, and drafts the update to your compliance program for your approval. Nothing changes without you.

Get startedLive demo

Olivra lists official notices for information only. It is not legal advice, and Olive is not a lawyer or a licensed customs broker. The official text at the source is what counts.

More from FDA

See everything Olive monitors