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Concept Arthroscopic Portal Rod

by Concept, Inc. 510(k)

Active United States

510(k) K873030

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873030 Date16 Sep 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
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 Concept Arthroscopic Portal Rod is an arthroscopic device designed to establish and maintain surgical portals during arthroscopic procedures. It falls under the classification of orthopedic instruments, specifically aiding in the precise insertion and guidance of cannulas and other instruments through soft tissue. Its rigid rod design ensures stability and accuracy during minimally invasive joint surgeries, such as those involving the knee or shoulder.

This device is supplied as a reusable surgical instrument and is intended for use in operating room settings. It is not classified as single-use or sterile upon packaging but must be sterilized prior to use in accordance with standard medical device sterilization protocols. The device is regulated under the FDA’s 510(k) clearance process, with clearance number K873030 granted under the product code HRX. No additional regulatory status beyond the stated FDA clearance is implied.

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