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American Dilatation System

by American Endoscopy, Inc.

510(k) K853274

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853274 Date17 Oct 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KNQ
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 American Dilatation System is an esophageal dilator designed for the mechanical dilation of esophageal strictures. It is classified as a Class 2 medical device under the FDA’s product code KNQ, intended for use in gastroenterology and urology procedures. The system consists of reusable polyvinyl dilators that are radiopaque, allowing for visualization during fluoroscopic guidance.

This over-the-wire system is supplied in a range of diameter sizes to accommodate varying stricture widths. It is intended for reusable use and requires sterilization between procedures. The device was cleared through the FDA’s Traditional 510(k) pathway in 1985 under clearance number K853274, adhering to regulatory standards for Class 2 devices. No additional regulatory markings beyond the FDA clearance are specified.

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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 is the American Dilatation System used for?

    The American Dilatation System is designed specifically for the mechanical dilation of esophageal strictures. It uses a reusable, radiopaque polyvinyl dilator that allows for real-time visualization during fluoroscopic procedures, ensuring precise placement and effective widening of narrowed esophageal passages.

  • How is the American Dilatation System supplied, and what sizes are available?

    The system is supplied as a reusable set of polyvinyl dilators in a range of diameter sizes to accommodate varying stricture widths. The exact sizes correspond to the listed registration numbers in the FDA database, ensuring compatibility with different clinical needs for esophageal dilation.

  • Is the American Dilatation System single-use or reusable?

    This device is intended for reusable use. Between procedures, it must be properly sterilized to maintain safety and efficacy, adhering to standard medical device reprocessing protocols for reusable instruments.

  • Why is the American Dilatation System radiopaque?

    The radiopaque design of the dilators allows for clear visualization under fluoroscopy, enabling clinicians to guide the device accurately during dilation procedures. This feature reduces the risk of misplacement and improves procedural precision.

  • What regulatory pathway was followed for the American Dilatation System?

    The American Dilatation System was cleared through the FDA’s Traditional 510(k) pathway in 1985 under clearance number K853274. It is classified as a Class 2 medical device under product code KNQ, adhering to regulatory standards for devices intended for gastroenterology and urology procedures.