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Amcath Ureteral Dilators Models 7100, 7110, 7120

FDA 510(k)

Class II (US FDA 510(k))

510(k) K894925

by Intec Medical, Inc.

Identifiers

510(k) Number
K894925 FDA 510(k)
FDA Product Code
EZN FDA 510(k)
Models / Variants
7100 FDA 510(k)
7110 FDA 510(k)
7120 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5470 FDA 510(k)
Regulation Number
876.5470 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Amcath Ureteral Dilators Models 7100, 7110, and 7120 are ureteral dilators designed to facilitate the dilation of the ureteral lumen. These devices fall under the category of dilators and catheters, specifically for ureteral use, and are intended to assist in procedures related to urinary tract management.

These dilators are supplied sterile and intended for single-use. They are classified under FDA product code EZN and have received a 510(k) clearance, demonstrating substantial equivalence to a predicate device. The devices are regulated under the U.S. FDA as Class II medical devices under special controls, with no third-party involvement in the review process. They are manufactured by Intec Medical, Inc., and are intended for use in clinical settings by trained medical professionals.

Frequently asked questions

Are these ureteral dilators reusable or intended for single-use only, and how should they be handled after use?

The Amcath Ureteral Dilators (Models 7100, 7110, and 7120) are explicitly designed for single-use only. Since they are supplied sterile, they should not be reused or reprocessed. After use, they must be discarded according to standard medical waste protocols to prevent contamination and ensure patient safety.

What medical specialties are these dilators primarily associated with, and how does that relate to their intended use?

These dilators fall under the Gastroenterology and Urology specialties, as indicated by their regulatory classification and advisory committee designation. This reflects their role in procedures related to urinary tract management, such as ureteral dilation, which may be performed by urologists or gastroenterologists in clinical settings.

How are these dilators supplied, and what should clinicians verify before use to ensure proper application?

The Amcath Ureteral Dilators are supplied sterile and come in multiple models (7100, 7110, 7120), likely corresponding to different sizes or dilation strengths. Clinicians should verify the model number matches the patient’s anatomical requirements and confirm the sterility seal remains intact before use to maintain aseptic conditions during the procedure.

What storage conditions should be followed for these dilators to maintain their sterility and functionality?

While the exact storage instructions aren’t detailed in the data, standard practice for sterile, single-use medical devices like these requires keeping them in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s (Intec Medical, Inc.) printed instructions if additional guidance is provided.

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: K894925 FDA 510 (k) - AMCATH URETERAL DILATORS MODELS 7100, AMCATH URETERAL DILATORS MODELS 7100,7110,7120 (K894925) — FDA 510(k ..., Amcath Ureteral Dilators Models 7100,7110,7120 - Beudamed, PDF K894925 - Amcath Ureteral Dilators Models 7100,7110,7120, AMCATH URETERAL DILATORS MODELS 7100,7110,7120… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Intec Medical, Inc.

Sources (1)

  • FDA 510(k) K894925 24 fields · synced Sep 20, 2026