Skip to content

Colorado Needle Electrode

by Colorado Biomedical, Inc.

510(k) K881763

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881763 Date20 Jun 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Colorado Needle Electrode is an electrosurgical electrode designed for precision cutting, dissecting, and cauterizing soft tissue. It is classified as an electrosurgical electrode and is intended for use in surgical procedures requiring fine control and accuracy, particularly in general and plastic surgery applications. Its sharp, fine point facilitates controlled tissue manipulation through confined or complex surgical fields.

This device is supplied as a single-use, non-sterile item and requires sterilization prior to use. It is intended for use in electrosurgical procedures and has been cleared by the FDA under 510(k) number K881763. The electrode falls under regulation number 878.4400 and is categorized under product code JOS, with a device class of II. It is not MRI-safe and must be used in accordance with standard surgical and electrosurgical safety protocols.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Colorado Needle Electrode used for?

    The Colorado Needle Electrode is designed for electrosurgical procedures requiring precision, such as cutting, dissecting, and cauterizing soft tissue. Its sharp, fine point allows controlled manipulation in confined or complex surgical fields, making it particularly useful in general and plastic surgery applications.

  • Is the Colorado Needle Electrode sterile when supplied?

    No, the Colorado Needle Electrode is supplied as a single-use, non-sterile item. It must be sterilized prior to use in accordance with standard surgical protocols to ensure patient safety.

  • Can the Colorado Needle Electrode be reused?

    No, the Colorado Needle Electrode is intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and performance.

  • What regulatory approval does the Colorado Needle Electrode have?

    The Colorado Needle Electrode has been cleared by the FDA under 510(k) number K881763. It falls under regulation number 878.4400 and is categorized under product code JOS with a device class of II.

  • Is the Colorado Needle Electrode MRI-safe?

    No, the Colorado Needle Electrode is not MRI-safe. It must be used in accordance with standard surgical and electrosurgical safety protocols, and its use in MRI environments is not recommended.