FAT · Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Gastroenterology, Urology · 21 CFR 876.5365 · Class 2
Overview
| Product Code | FAT |
|---|---|
| Device Name | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology |
| Regulation | 21 CFR 876.5365 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
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.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K133439 | PILLING ESOPHAGEAL BOUGIES | Teleflexmedical, Inc. | Jun 16, 2014 | SESE |
| K983220 | STRYKER INFRAVISION ESOPHAGEAL KIT | Stryker Endoscopy | Jun 4, 1999 | SESE |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Medovations, Inc. | Feb 2, 1998 | SESE |
| K960173 | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | Gabriel Medical, Inc. | Jun 27, 1996 | SESE |
| K901425 | PYLORIC BALLOON DILATOR | Telemed Systems, Inc. | Jun 21, 1990 | SESE |
| K843186 | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | Dacomed Corp. | Jan 18, 1985 | SESE |
| K842679 | ESOPHAGEAL DILATOR SET | Mill-Rose Laboratory | Oct 2, 1984 | SESE |
| K780471 | GASTRIC LAVAGE KIT | Gaymar Industries, Inc. | Jun 2, 1978 | SESE |
Top Applicants
- Dacomed Corp. — 1 clearance
- Gabriel Medical, Inc. — 1 clearance
- Gaymar Industries, Inc. — 1 clearance
- Medovations, Inc. — 1 clearance
- Mill-Rose Laboratory — 1 clearance
