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Percutaneous Discectomy Cannula System

by T. Korossurgical Instruments Corp. 510(k)

Active United States

510(k) K954014

Overview

The Percutaneous Discectomy Cannula System is a device designed for percutaneous discectomy procedures. It is classified under the orthopedic advisory committee and was substantially equivalent for some indications as determined by FDA 510(k) clearance.

The system was cleared via the traditional 510(k) pathway on November 6, 1995, under K954014. It is manufactured by T. Korossurgical Instruments Corp. and is authorized for distribution in the United States. The device is supplied as a reusable or single-use system based on its configuration, though specific sterility, MRI safety, size, and storage details are not provided in the data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK954014 Date6 Nov 1995DecidedStatusActive

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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SN

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Questions

  • What is the Percutaneous Discectomy Cannula System used for?

    The Percutaneous Discectomy Cannula System is designed for percutaneous discectomy procedures, which involve removing herniated disc material through a needle-like approach to relieve nerve pressure in the spine.

  • Is the Percutaneous Discectomy Cannula System reusable or single-use?

    The system is supplied as either reusable or single-use depending on its specific configuration, as stated in the device data, though the exact configuration determining reuse status is not detailed in the provided information.

  • When was the Percutaneous Discectomy Cannula System cleared by the FDA?

    The device was cleared via the traditional 510(k) pathway on November 6, 1995, under submission number K954014, as indicated in the authorization and specification fields of the device data.