---
kind: "section"
citation: "21 C.F.R. § 876.5360"
title: "21"
number: "876.5360"
heading: "Laparoscopic gastrointestinal sizing tool."
url: "https://uscodex.org/cfr/21/876.5360"
---

# §876.5360. Laparoscopic gastrointestinal sizing tool.

- (a) **Identification.** A laparoscopic gastrointestinal sizing tool is a prescription use device intended for laparoscopically measuring an extraluminal dimensional parameter of the indicated gastrointestinal organs.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following:
    - (i) Trocar compatibility, which includes shaft bending force characterization;
    - (ii) Joint strength tensile testing;
    - (iii) Distal loop extension/retraction force characterization;
    - (iv) Material selection analysis, which includes corrosion and visual inspection; and
    - (v) **Accuracy of the dimensional measurement.**
  - (2) Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device.
  - (3) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Labeling of the device must include the following:
    - (i) A statement regarding metal allergies if the device is made from metallic components;
    - (ii) **Specific instructions for proper device use including information regarding the following—**
      - (A) Inspection of device prior to use;
      - (B) Surgical access techniques or methodologies;
      - (C) Instructions for avoiding structural damage to vagus nerve bundle;
      - (D) Trocar compatibility;
      - (E) Sizing methodology; and
      - (F) **Minimum and maximum dimensional parameters that the device is capable of measuring.**
    - (iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and
    - (iv) **An expiration date.**

## Notes

### Amendments

[90 FR 40730, Aug. 21, 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 40730, Aug. 21, 2025]