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Christoudias Slim Tip Electrode Insert

by Innervision, Inc.

510(k) K992345

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992345 Date10 Sep 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

The Christoudias Slim Tip Electrode Insert is a surgical instrument designed for use during laparoscopic procedures. It functions as an electrode that provides coagulation to control small bleeding vessels.

The device is cleared under FDA 510(k) submission K992345 (decision date 1999-09-10) and is classified as Class II with product code GEI. It is supplied by Innervision, Inc. for sterile, single‑use application in the operating room, and is intended for use in general and plastic surgery settings.

Other devices from Innervision, Inc.

Questions

AI-generated answers, 28 Sep 2026

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

  • What surgical procedures is the Christoudias Slim Tip Electrode Insert intended for?

    It is designed for laparoscopic use in general and plastic surgery, where precise coagulation of small bleeding vessels is needed to control intra‑operative bleeding.

  • How is the device supplied and what is its sterility status?

    The insert is supplied by Innervision, Inc. in a sterile package intended for single‑use application in the operating room, ensuring aseptic conditions for each procedure.

  • Is the Christoudias Slim Tip Electrode Insert reusable or single‑use only?

    It is a single‑use device; after one procedure the electrode insert must be discarded to maintain safety and prevent cross‑contamination.

  • What regulatory pathway was used for market clearance of this device?

    The device received FDA clearance through a traditional 510(k) submission (K992345) on September 10, 1999, and is classified as a Class II product with product code GEI.

  • Are there different sizes or models of the Slim Tip Electrode Insert available?

    The provided data describe only one model, the Christoudias Slim Tip Electrode Insert, without mention of alternative sizes or variations.