KEYMED FLEXIBLE ESOPHAGEAL DILATORS
Device Facts
| Record ID | K862000 |
|---|---|
| Device Name | KEYMED FLEXIBLE ESOPHAGEAL DILATORS |
| Applicant | Keymed, Inc. |
| Product Code | KNQ · Gastroenterology, Urology |
| Decision Date | Aug 12, 1986 |
| 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.
