Lariat Hot/Cold Snare
by United States Endoscopy Group, Inc.
510(k) K200745
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200745 | Date21 Apr 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lariat Hot/Cold Snare is a flexible endoscopic snare designed for grasping, dissecting, and transecting tissue during gastrointestinal procedures. Classified as a Snare, Flexible, it is intended for use in polypectomy—both hot and cold—where precise tissue removal is required. The device incorporates a multi-shape snare loop and an integrated injection needle, enabling simultaneous tissue manipulation and fluid injection through flexible endoscopes.
Supplied as a single-use, non-sterile device (sterilized prior to use), the Lariat Hot/Cold Snare is regulated under 21 CFR 876.4300 as an accessory for endoscopic electrosurgical units. It is intended for use in Gastroenterology and Urology settings and is classified as a Class II medical device. The device is authorized via FDA 510(k) clearance (K200745) and must be sterilized by the end-user prior to clinical application. No MRI safety information is specified.
From the manufacturer
The Lariat snare is intended to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures. The Lariat snare can be used for hot or cold snare polypectomy.
How the iSnare System - Lariat Snare works The iSnare system - Lariat snare is a single catheter device incorporating both an injection needle and multi-shape polypectomy snare to be used through flexible endoscopes. The needle is intended to be used for the injection of various types of media.
Other devices from United States Endoscopy Group, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Lariat Hot/Cold Snare used for?
The Lariat Hot/Cold Snare is designed for grasping, dissecting, and transecting tissue during gastrointestinal procedures, specifically for polypectomy—both hot and cold. Its multi-shape snare loop and integrated injection needle allow simultaneous tissue manipulation and fluid injection, making it ideal for precise tissue removal in Gastroenterology and Urology settings.
Is the Lariat Hot/Cold Snare single-use or reusable?
The Lariat Hot/Cold Snare is supplied as a single-use device. It is non-sterile and must be sterilized by the end-user prior to clinical application, as specified in the device documentation.
How should the Lariat Hot/Cold Snare be stored?
The Lariat Hot/Cold Snare is non-sterile and must be sterilized by the end-user before use. Storage instructions are not explicitly detailed in the provided data, but it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until sterilization and use.
What regulatory approval does the Lariat Hot/Cold Snare have?
The Lariat Hot/Cold Snare is authorized via FDA 510(k) clearance (K200745) and classified as a Class II medical device. It is regulated under 21 CFR 876.4300 as an accessory for endoscopic electrosurgical units.
Can the Lariat Hot/Cold Snare be used with MRI equipment?
The provided data does not specify MRI safety information for the Lariat Hot/Cold Snare, so its compatibility with MRI equipment cannot be confirmed. Caution should be exercised, and manufacturer guidelines should be followed.