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Esophageal And Pyloric Balloon Dialators

FDA 510(k)

Class II (US FDA 510(k))

510(k) K884712

by Primrose Medical, Inc.

Identifiers

510(k) Number
K884712 FDA 510(k)
FDA Product Code
KNQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5365 FDA 510(k)
Regulation Number
876.5365 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Esophageal and Pyloric Balloon Dilators are medical devices classified as Dilator, Esophageal, designed for controlled dilation of the esophagus and pyloric regions. These devices utilize inflatable balloons to mechanically widen strictures or obstructions in these anatomical areas, facilitating passage of fluids or instruments.

These dilators are supplied as single-use, non-sterile devices intended for use in clinical settings such as gastroenterology and urology procedures. They are regulated under FDA 510(k) clearance (K884712) and fall under Device Class II (Regulation 876.5365). No third-party review was conducted, and their use is governed by standard medical practice guidelines for dilation procedures.

Frequently asked questions

Are these dilators intended for reuse in clinical settings, or are they designed as single-use devices?

These dilators are explicitly supplied as single-use devices, meaning they are not intended for reuse after a single procedure. This aligns with standard medical practice for dilation tools to ensure patient safety and sterility, as they are provided in a non-sterile state for preparation in a clinical environment.

What anatomical regions do these dilators target, and how do they function?

These dilators are designed specifically for controlled dilation of the esophagus and pyloric regions. They use inflatable balloons to mechanically widen strictures or obstructions, allowing for smoother passage of fluids or instruments. The device is categorized under Dilator, Esophageal in regulatory records, confirming its intended use.

Do these devices require sterilization before use, or are they pre-sterilized?

The dilators are non-sterile as supplied, meaning they must be sterilized in the clinical setting before use. This is a common practice for single-use devices that require preparation for sterile procedures, ensuring compliance with infection control protocols.

What regulatory pathway was followed for FDA clearance of these dilators?

The device received FDA 510(k) clearance under the traditional review pathway (K884712) and is classified as Class II. The submission was filed in 1988 and determined to be substantially equivalent to a predicate device. No third-party review was conducted, and the device falls under regulation 876.5365 for esophageal dilators.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (K884712) — FDA 510 (k ..., ESOPHAGEAL AND PYLORIC BALLOON DIALATORS 510(k) K884712 - fda.report, Balloon Dilators - Gastroenterology - Olympus

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Primrose Medical, Inc.

Sources (1)

  • FDA 510(k) K884712 24 fields · synced Sep 19, 2026