Endocoagulator 2001 KLI

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K895402 ↗

FDA Product Code

HGI

Device Class

Class II

Regulation

21 CFR Part 884.4120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Cabot Medical Optima Hand Instruments

  Class II

  FDA 510(k) K932977 Active Cleared 7 Sep 1993

• Cabot Medical Surgiflex(R) Suction-Irrigation Prob

  Class II

  FDA 510(k) K932626 Active Cleared 8 Jun 1994

• Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths

  Class II

  FDA 510(k) K951972 Active Cleared 21 Jul 1995

• Cabot Disposable 10mm Suction Device

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  FDA 510(k) K924048 Active Cleared 22 Jan 1993

• Pleatman Sac Specimen Container

  Class II

  FDA 510(k) K923945 Active Cleared 5 Feb 1993

• Corson and Nezhat Suction/Irrigation Probes

  Class II

  FDA 510(k) K935786 Active Cleared 19 May 1994

See all devices from Cabot Medical Corp. →

• What is the Endocoagulator 2001 KLI used for?

  The Endocoagulator 2001 KLI is designed specifically for gynecologic procedures to deliver controlled electrical energy. It coagulates and seals tissues, helping to minimize bleeding during endoscopic and laparoscopic surgeries in obstetrics and gynecology. This makes it particularly useful in procedures where precise tissue control is critical, such as hysteroscopies or laparoscopic myomectomies.

• Is the Endocoagulator 2001 KLI reusable or single-use?

  The Endocoagulator 2001 KLI is classified as a reusable medical device. However, it is intended for single-patient use per procedure, adhering to standard surgical sterility protocols. This means it must be sterilized between uses on different patients to maintain safety and compliance with medical standards.

• How should the Endocoagulator 2001 KLI be stored?

  While the regulatory data does not specify detailed storage instructions, reusable medical devices like the Endocoagulator 2001 KLI should generally be stored in a clean, dry environment, protected from contamination and physical damage. After use, it must undergo proper sterilization before storage to ensure it remains safe for subsequent procedures. Always follow the manufacturer’s guidelines for cleaning and sterilization.

• What regulatory pathway does the Endocoagulator 2001 KLI follow?

  The Endocoagulator 2001 KLI is cleared under the FDA’s 510(k) pathway, specifically classified as a Class II device. It was granted clearance on April 26, 1990, with the decision code SESE (Substantially Equivalent) under the traditional review process. This classification and clearance indicate it meets FDA standards for safety and effectiveness as an electrocautery device for gynecologic use.

• Can the Endocoagulator 2001 KLI be used in MRI environments?

  The regulatory data for the Endocoagulator 2001 KLI does not provide any information regarding its safety in MRI environments. If MRI compatibility is required, additional research or manufacturer documentation should be consulted to ensure safe use in such settings.