Over The Guidewire Dilatation System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K924646 ↗

FDA Product Code

KNQ

Device Class

Class II

Regulation

21 CFR Part 876.5365

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 5 - in - 1 Connector

  Class II

  FDA 510(k) K864964 Active Cleared 20 Jan 1987

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

  Class II

  FDA 510(k) K972119 Active Cleared 2 Feb 1998

• Oxygen Catheters

  Class I

  FDA 510(k) K830984 Active Cleared 18 May 1983

• Oberto Mouth Prop

  Class II

  FDA 510(k) K864962 Active Cleared 19 Feb 1987

• Cantor Tube

  Class II

  FDA 510(k) K831009 Active Cleared 2 Jun 1983

• Medovations Esophageal Dilator

  Class II

  FDA 510(k) K002363 Active Cleared 1 Nov 2000

See all devices from Medovations, Inc. →

• What is the Over The Guidewire Dilatation System used for?

  This esophageal dilator is designed to be advanced over a pre-positioned guidewire to treat upper esophageal webs, lower esophageal rings, caustic or peptic strictures, and provide temporary relief for esophageal carcinoma lesions.

• In what sizes is the Over The Guidewire Dilatation System available?

  The system is supplied in sixteen different sizes ranging from 15 French (FR) to 60 FR, allowing clinicians to select the appropriate diameter for individual patient needs.

• What is the regulatory status of this device?

  The Over The Guidewire Dilatation System has received traditional 510(k) clearance (K924646) from the FDA and is classified as a Class II medical device with product code KNQ.

• Is this device reusable or single-use?

  The device data does not specify whether this dilator is designed for single-use or multiple uses. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocol.