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BITX PROBES

by Everest Medical Corp. 510(k)

Active United States

510(k) K994336

Overview

The BITX PROBES are electrosurgical devices intended for the cutting and coagulation of soft tissue during ENT procedures. They function as surgical instruments that utilize electrical energy to perform both cutting and hemostatic functions in a single device.

These single-use probes are supplied sterile and are designed for arthroscopic and general plastic surgery applications. The device is regulated under the GEI product code and received FDA 510(k) clearance under number K994336, with a decision date of February 8, 2000. Storage conditions and specific size variants are not detailed in the available specifications.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994336 Date8 Feb 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What procedures are BITX PROBES designed for?

    BITX PROBES are designed for cutting and coagulation of soft tissue during ENT (ear, nose, and throat) procedures. They are also indicated for use in arthroscopic and general plastic surgery applications, functioning as dual-purpose electrosurgical instruments.

  • Are BITX PROBES supplied sterile and for single use?

    Yes, BITX PROBES are supplied sterile and are intended for single use only. This ensures patient safety by eliminating the risk of cross-contamination and maintaining device integrity for each surgical application.

  • What is the regulatory status of BITX PROBES?

    BITX PROBES received FDA 510(k) clearance under number K994336, with a decision date of February 8, 2000. The device is classified under the GEI product code and was determined to be substantially equivalent to existing legally marketed devices.

  • Who is the manufacturer and where is it located?

    BITX PROBES are manufactured by Everest Medical Corp., located at 13755 First Ave., N., Suite 500, Minneapolis, MN 55441, United States. The company is listed as the applicant in the FDA 510(k) submission.

  • What type of energy do BITX PROBES use?

    BITX PROBES are electrosurgical devices that utilize electrical energy to perform both cutting and hemostatic (coagulation) functions. This allows surgeons to achieve tissue division and bleeding control in a single instrument during soft tissue procedures.