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AcuSnare Polypectomy Snare - Duckbill

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191048

by Wilson-Cook Medical, Inc.

Identifiers

510(k) Number
K191048 FDA 510(k)
FDA Product Code
FDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4300 FDA 510(k)
Regulation Number
876.4300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AcuSnare Polypectomy Snare - Duckbill is a flexible endoscopic snare device designed for the removal and cauterization of sessile and pedunculated polyps within the gastrointestinal tract. Classified as a flexible snare, it is intended for use in gastroenterology and urology procedures to facilitate polyp excision during endoscopic interventions.

This device is supplied sterile and intended for single-use. It is compatible with MRI environments and is available in a 240 cm length (reference code G22647). Authorized under FDA 510(k) clearance (K191048) and MDR, it adheres to regulatory standards for flexible endoscopic snares, ensuring compliance with medical device regulations for gastrointestinal applications.

Manufacturer's product page: AcuSnare® Polypectomy Snare

Frequently asked questions

What types of polyps is the AcuSnare Polypectomy Snare - Duckbill designed to remove, and how does its duckbill shape assist in this process?

The AcuSnare Polypectomy Snare - Duckbill is specifically designed for the removal of both sessile (flat) and pedunculated (stalked) polyps within the gastrointestinal tract. The duckbill shape of the snare helps to securely grasp and isolate polyps during excision, reducing the risk of incomplete removal or tissue damage. This design also aids in precise cauterization, ensuring effective polyp ablation while minimizing bleeding.

Is the AcuSnare Polypectomy Snare - Duckbill compatible with MRI environments, and how does this benefit clinical workflows?

Yes, the AcuSnare Polypectomy Snare - Duckbill is explicitly stated as compatible with MRI environments. This compatibility allows clinicians to use the device in procedures where MRI imaging may be required for guidance or follow-up, reducing the need for device changes or additional equipment. It streamlines workflows, particularly in complex cases where imaging is critical.

How is the AcuSnare Polypectomy Snare - Duckbill supplied, and what are the implications for clinical use?

The AcuSnare Polypectomy Snare - Duckbill is supplied sterile and intended for single-use only. This ensures infection control and eliminates the need for reprocessing, which simplifies clinical workflows and reduces the risk of cross-contamination. Single-use also guarantees consistent performance and reliability for each procedure.

What length is the AcuSnare Polypectomy Snare - Duckbill, and how does this length support its intended use?

The device is available in a 240 cm length, which provides sufficient reach for endoscopic procedures in the gastrointestinal tract. This length accommodates various patient anatomies and procedural depths, allowing clinicians to access and remove polyps in both upper and lower GI regions with flexibility and precision.

What regulatory pathways has the AcuSnare Polypectomy Snare - Duckbill followed, and what does this mean for its clinical adoption?

The device has undergone FDA 510(k) clearance (K191048) and complies with the EU Medical Device Regulation (MDR). This regulatory approval ensures that the AcuSnare Polypectomy Snare - Duckbill meets stringent safety and performance standards for flexible endoscopic snares in gastroenterology and urology. Clinicians can rely on its compliance with established medical device regulations, reinforcing its suitability for clinical use in these specialties.

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: AcuSnare® Polypectomy Snare - Duck Bill - Cook Medical, AcuSnare® Polypectomy Snare - Duck Bill | Cook Medical, AcuSnare® Polypectomy Snare - Duck Bill - Cook Medical, AcuSnare Polypectomy Snare - Duckbill (K191048) — FDA 510(k ..., Cook Medical AcuSnare Polypectomy Snare Duck-Bill 240 cm - G22647

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.

Sources (2)

  • FDA 510(k) K191048 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026