Esophageal Dilator Set
510(k) K842679
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842679 | Date2 Oct 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FAT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5365
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Esophageal Dilator Set is a device that consists of a cylindrical instrument used to dilate a stricture of the esophagus. It may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire. This device is classified as a Bougie, Esophageal, And Gastrointestinal, Gastro-Urology device. The device is used in the medical specialty of Gastroenterology and Urology.
The Esophageal Dilator Set is supplied with a product code of FAT and is regulated under regulation number 876.5365. The device has been cleared with a substantially equivalent decision, with an FDA 510K clearance number of K842679. The set is available with the specified product code and regulation number, and is intended for use in a clinical setting.
Other devices from Mill-Rose Laboratory
Questions
AI-generated answers, 25 Sep 2026
What is the Esophageal Dilator Set used for?
The Esophageal Dilator Set is used to dilate a stricture of the esophagus, which is a narrowing of the esophagus that can cause difficulty swallowing.
Is the Esophageal Dilator Set supplied sterile?
The description does not specify if the Esophageal Dilator Set is supplied sterile, but it is intended for use in a clinical setting where sterility is typically required.
What is the product code for the Esophageal Dilator Set?
The product code for the Esophageal Dilator Set is FAT, and it is regulated under regulation number 876.5365.
Is the Esophageal Dilator Set a single-use or reusable device?
The description does not specify if the Esophageal Dilator Set is single-use or reusable, but it is typically used in a clinical setting where devices are carefully cleaned and sterilized between uses.