FDAFinal Rule
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
HealthcareTechnology
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Summary
The FDA is officially classifying a new medical device called the Anchored Esophageal Sheath, which is used in gastroenterology and urology procedures. This classification determines how strictly the device will be regulated and what safety requirements manufacturers must meet before selling it to hospitals and patients.
Key Points
- 1The FDA has decided on a regulatory classification for the Anchored Esophageal Sheath, a medical device used in digestive and urinary tract procedures
- 2This classification determines what safety testing and approval steps device manufacturers must complete before the product can be sold
- 3The decision affects medical device companies that want to produce or sell this type of sheath device
- 4Hospitals and healthcare providers will know what safety standards this device has met before using it on patients
- 5The rule was published on November 26, 2025, and is now official FDA policy
Key Dates
Published
November 26, 2025
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
The Digest Network
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