21 CFR 876.5365 — Dilator, Esophageal (Metal Olive) Gastro-Urology
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5365
Identification
An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EZM | Dilator, Esophageal (Metal Olive) Gastro-Urology | 2 | 0 | |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 2 | 8 | |
| KNQ | Dilator, Esophageal | 2 | 40 | |
| PRQ | Esophageal Dilator Kit | 2 | 0 |
Special Controls
EZM — Dilator, Esophageal (Metal Olive) Gastro-Urology
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
KNQ — Dilator, Esophageal
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
PRQ — Esophageal Dilator Kit
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
