Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5365](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5365) → FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

# FAT · Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

_Gastroenterology, Urology · 21 CFR 876.5365 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT

## Overview

- **Product Code:** FAT
- **Device Name:** Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
- **Regulation:** [21 CFR 876.5365](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5365)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K133439.md) | PILLING ESOPHAGEAL BOUGIES | Teleflexmedical, Inc. | Jun 16, 2014 | SESE |
| [K983220](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K983220.md) | STRYKER INFRAVISION ESOPHAGEAL KIT | Stryker Endoscopy | Jun 4, 1999 | SESE |
| [K972119](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K972119.md) | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Medovations, Inc. | Feb 2, 1998 | SESE |
| [K960173](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K960173.md) | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | Gabriel Medical, Inc. | Jun 27, 1996 | SESE |
| [K901425](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K901425.md) | PYLORIC BALLOON DILATOR | Telemed Systems, Inc. | Jun 21, 1990 | SESE |
| [K843186](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K843186.md) | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | Dacomed Corp. | Jan 18, 1985 | SESE |
| [K842679](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K842679.md) | ESOPHAGEAL DILATOR SET | Mill-Rose Laboratory | Oct 2, 1984 | SESE |
| [K780471](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT/K780471.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FAT)

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