PYLORIC BALLOON DILATOR
Device Facts
| Record ID | K901425 |
|---|---|
| Device Name | PYLORIC BALLOON DILATOR |
| Applicant | Telemed Systems, Inc. |
| Product Code | FAT · Gastroenterology, Urology |
| Decision Date | Jun 21, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5365 |
| Device Class | Class 2 |
Regulatory Classification
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).
Special Controls
*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.
