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Maloney Bouge (1210-XX) / Hurst Bougie (1212-XX)

by Medovations, Inc.

510(k) K972119

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972119 Date2 Feb 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Maloney Bouge (1210-XX) and Hurst Bougie (1212-XX) are esophageal and gastrointestinal bougies used for dilation. They are designed to treat various esophageal conditions, including upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures, and esophageal carcinoma. The bougies are tungsten-filled, providing a single style of dilator for treating esophageal diseases.

The Maloney Bouge (1210-XX) and Hurst Bougie (1212-XX) are supplied with specific model numbers and are regulated under the product code FAT. They have been authorized with an FDA 510(k) clearance, specifically K972119. The devices are used in gastroenterology and urology, and their regulation number is 876.5365. They are designed to be introduced through the cricopharynx area, cardioesophageal junction, or stenosis, and the tapered end allows for dilation of the esophagus.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Maloney Bouge and Hurst Bougie used for?

    The Maloney Bouge and Hurst Bougie are used for dilation of various esophageal conditions, including upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures, and esophageal carcinoma.

  • How are the bougies supplied?

    The Maloney Bouge and Hurst Bougie are supplied with specific model numbers, including 1210-XX and 1212-XX.

  • What material are the bougies filled with?

    The bougies are tungsten-filled, providing a single style of dilator for treating esophageal diseases.

  • What is the regulatory classification of the devices?

    The devices are regulated under the product code FAT and have a regulation number of 876.5365.