Spinal Foraminoscope Endoscope Device

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK082841	Date9 Sep 2009Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K082841

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K082841
FDA product code: HRX

Device class: Class II
Regulation: 21 CFR Part 888.1100
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Spine Scope, Model 2180 K011454 13 Dec 2001 FDA record
Yeung Endoscopic Spine System K973405 13 Mar 1998 FDA record
Pollux Oa/Pollux 30A/Pollux 70A K953484 1 Sep 1995 FDA record

Cited by

Needle View Ch Scope Kits K141326 8 Oct 2014 FDA record · FDA summary
Discoscopes, Cervical Endoscopes K130778 14 Apr 2014 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

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 Spinal Foraminoscope is a medical endoscope device used for visualization during spinal procedures. It is designed for minimally invasive surgical applications, allowing for examination and treatment within the spinal foramen.

The device is supplied by Blazejewski MEDI-TECH GmbH and has received FDA 510(k) clearance with the product code HRX. It is manufactured in Amsterdam, Netherlands, and is intended for use in orthopedic procedures. The device is not specified as single-use or reusable, and no MRI safety information is provided.

From the manufacturer

Erbe Vision GmbH We are a member of the ERBE group and OEM-manufacturer of medical endoscopes and visualisation units for minimally invasive and surgical applications. Being a certified (DIN EN ISO 13485) company we develop, manufacture and distribute products that are tailor-made according to the requirements of our customers.

Source: blazejewski.de

Erbe Vision GmbH Wir sind ein Unternehmen der Erbe-Group und OEM-Hersteller von medizinischen Endoskopen und Visualisierungsgeräten für minimalinvasive und chirurgische Anwendungen. Als zertifiziertes Unternehmen nach DIN EN ISO 13485, entwickeln, fertigen und vertreiben wir Produkte, maßgeschneidert auf die Wünsche unserer Kunden.