---
kind: "section"
citation: "21 C.F.R. § 876.1510"
title: "21"
number: "876.1510"
heading: "Anchored esophageal sheath."
url: "https://uscodex.org/cfr/21/876.1510"
---

# §876.1510. Anchored esophageal sheath.

- (a) **Identification.** An anchored esophageal sheath is a device used to provide an endoluminal pathway to facilitate insertion of an endoscope or other compatible device into the upper gastrointestinal tract. A distal anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other compatible device.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
    - (i) Testing must verify all dimensions;
    - (ii) Testing must demonstrate that insertion and removal of any device from the anchored esophageal sheath does not damage the shaft wall or exert force that would cause tissue injury;
    - (iii) Testing must demonstrate that the anchoring component can be reliably actuated;
    - (iv) Testing must demonstrate compatibility with any other device that the anchored esophageal sheath is intended to be used with; and
    - (v) Testing must demonstrate device integrity and functionality in simulated gastric conditions under clinically anticipated forces.
  - (3) Simulated use testing using an anatomically accurate gastrointestinal model must demonstrate that:
    - (i) The device can be inserted and removed safely;
    - (ii) The device remains anchored in place;
    - (iii) The device can be safely withdrawn after releasing the anchor; and
    - (iv) **The device location and anchoring status can be observed by the intended user.**
  - (4) Performance data must demonstrate continued device functionality over the identified shelf life.
  - (5) Labeling must include:
    - (i) Information as to whether the device can be used for foreign body removal or with instruments alongside the endoscope;
    - (ii) Steps needed to prevent injury to the esophagus or gastroesophageal junction (GEJ) during placement, anchoring, and use of the device;
    - (iii) Any visualization steps required to confirm the device's placement prior to and after actuating the anchoring component at the GEJ;
    - (iv) A precaution to avoid excessive force during insertion;
    - (v) Identification of any endoscopes or other devices that have been validated for use with the anchored esophageal sheath; and
    - (vi) **An expiration date or shelf life.**

## Notes

### Amendments

[90 FR 54232, Nov. 26, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[90 FR 54232, Nov. 26, 2025]