Infrared Coagulator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K842810 ↗

FDA Product Code

KNS

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Endo Lase, Inc. →

• What is the primary use of the Infrared Coagulator in medical procedures?

  The Infrared Coagulator is designed to achieve hemostasis—stopping bleeding—during minimally invasive endoscopic procedures. It uses controlled thermal energy delivered via infrared radiation to coagulate tissue, making it particularly useful in gastroenterology and urology for procedures where precise tissue sealing is required.

• Is the Infrared Coagulator intended for single-use or reusable applications?

  This device is explicitly intended for single-use applications. It is supplied sterile and should not be reused, as reuse could compromise sterility and device performance. Adherence to single-use protocols ensures patient safety and maintains the device’s efficacy.

• What regulatory clearance does the Infrared Coagulator hold, and how does it classify?

  The Infrared Coagulator holds FDA 510(k) clearance under the reference number K842810, classifying it as a Class II medical device. It falls under the product code KNS (Unit, Electrosurgical, Endoscopic) and is categorized as substantially equivalent to predicate devices, ensuring its safety and effectiveness for intended use.

• Are there any special storage or handling requirements for the Infrared Coagulator beyond standard sterile protocols?

  No additional storage or handling specifications are noted beyond standard sterile instrument protocols. Since it is supplied sterile and intended for single-use, it should be stored in a clean, dry environment, protected from contamination until use, and discarded immediately after a single application to prevent cross-contamination.

• What medical specialties primarily utilize the Infrared Coagulator?

  The Infrared Coagulator is primarily utilized in gastroenterology and urology specialties. Its design supports endoscopic procedures where controlled tissue coagulation is required, such as during biopsies, polypectomies, or other minimally invasive interventions in these fields.