# 2025-21217: FDA Approves Mysterious 'Anchored Esophageal Sheath' Medical Device

2025-21217, Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2025-11-26, effective 2025-11-26 (as of 2026-06-11).

- Canonical: https://policyrisk.com/federal-register/2025-21217
- As of: 2026-06-11
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-21217
- Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 54230
- Published: 2025-11-26
- Effective: 2025-11-26
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-11

## In one line

FDA Approves Mysterious 'Anchored Esophageal Sheath' Medical Device

## Summary

The FDA is officially classifying the anchored esophageal sheath as a Class II medical device with special safety rules. This change helps make sure the device is safe and effective while making it easier for patients to get access to this helpful technology. The new rules took effect on November 26, 2025, and could reduce some regulatory hurdles for manufacturers.

## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is classifying the anchored esophageal sheath 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 the classification of the anchored esophageal sheath. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- Anchored esophageal sheath: Patient access: benefit, medium. The FDA classified the anchored esophageal sheath as a Class II (special controls) medical device effective November 26, 2025 (classification was applicable April 16, 2019). The FDA says this classification provides a reasonable assurance of safety and effectiveness and will enhance patients' acces…
- Manufacturers must submit 510(k) notice: cost, medium. The device is subject to premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act. Manufacturers seeking to market an anchored esophageal sheath must follow the 510(k) premarket notification pathway unless FDA later issues an exemption.
- Required special controls: testing & labeling: mixed, medium. The final order lists special controls manufacturers must meet, including biocompatibility testing, non-clinical performance testing (dimensions, insertion/removal safety, anchor actuation, compatibility, simulated gastric conditions), simulated use testing in an anatomically accurate model, shelf-…

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## Sources
- [2025-21217 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/26/2025-21217/medical-devices-gastroenterology-urology-devices-classification-of-the-anchored-esophageal-sheath)
- [2025-21217 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-26/pdf/2025-21217.pdf)

## Related
- [Previous: 2025-21215, Internal Governance](https://policyrisk.com/federal-register/2025-21215)
- [Next: 2025-21218, Medical Devices; Neurological Devices; Classification of Field Generator Positi…](https://policyrisk.com/federal-register/2025-21218)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-21217 (as of 2026-06-11).