Skip to content

Microvasive MaxForce Esophageal Dilator

by Boston Scientific

510(k) K934697

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK934697 Date16 May 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0831-03 FDA Unclassified (pre-2012) initiated 29 Apr 2003 on shared 510(k) K934697

    Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Microvasive Maxforce
510(k) Number
FDA product code
KNQ
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 876.5365
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Microvasive MaxForce Esophageal Dilator is a Dilator, Esophageal (per FDA nomenclature), designed for controlled dilation of the esophagus. It is a mechanical device used to gradually widen narrowed or constricted esophageal passages, facilitating passage of food, liquids, or medical instruments. Its construction and design are intended to provide precise control during dilation procedures, reducing the risk of complications such as perforation or excessive trauma to surrounding tissues.

This device is supplied as a single-use, non-sterile instrument, intended for use in clinical settings such as gastroenterology and urology. It is classified under 21 CFR 876.5365 and falls under FDA product code KNQ, with a Traditional 510(k) clearance (K934697) granted in 1994. The dilator is intended for professional medical use only and must be handled and disposed of according to established clinical protocols. No MRI safety information is specified in the available data.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Questions

AI-generated answers, 19 Sep 2026

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

  • What medical specialties primarily use the Microvasive MaxForce Esophageal Dilator, and why is it relevant to them?

    The Microvasive MaxForce Esophageal Dilator is primarily used in gastroenterology and urology specialties. It is relevant to gastroenterologists for controlled dilation of narrowed esophageal passages, improving swallowing function and allowing passage of food, liquids, or medical instruments. While its primary indication is esophageal, its inclusion in urology advisory committees suggests it may also be considered for related procedural applications in specialized cases, though the data does not specify urological use.

  • Is the Microvasive MaxForce Esophageal Dilator sterile, and how should it be handled in a clinical setting?

    The device is non-sterile and supplied for single-use only. It must be handled according to standard clinical protocols, including proper sterilization of the environment and instruments before use, as well as appropriate disposal after a single procedure to prevent contamination and ensure patient safety.

  • What regulatory pathway was followed for FDA clearance of the Microvasive MaxForce Esophageal Dilator, and when was it approved?

    The device received Traditional 510(k) clearance (K934697) under the FDA’s Substantially Equivalent (SESE) determination. It was granted in May 1994, following a review by the Gastroenterology and Urology (GU) Advisory Committee. The clearance confirms it meets FDA standards for esophageal dilators and is classified under 21 CFR 876.5365 with product code KNQ.

  • Are there multiple sizes or models of the Microvasive MaxForce Esophageal Dilator, and if so, how are they differentiated?

    The data lists multiple registration numbers (FEI numbers) associated with the device, which may correspond to different sizes, calibers, or variations of the MaxForce Esophageal Dilator. While exact specifications (e.g., diameters or lengths) are not provided, these variations likely cater to different clinical needs, such as varying degrees of esophageal stenosis or patient anatomy. For precise sizing, refer to the manufacturer’s product catalog or technical documentation.

  • Can the Microvasive MaxForce Esophageal Dilator be reused, or is it designed for one-time use?

    The device is explicitly labeled as single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, or patient safety. Clinical protocols must adhere to single-use guidelines to prevent cross-contamination and ensure proper procedural outcomes.