# K082841: Spinal Foraminoscope

- Pathway: 510(k) (Traditional)
- Applicant: Blazejewski Medi-Tech GmbH
- Decided: Sep 9, 2009 after 348 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953484 (1995). 3 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973405: Yeung Endoscopic Spine System, Richard Wolf Medical Instruments Corp. (1998) Summary page 1.
- K011454: Spine Scope, Model 2180, Clarus Medical, LLC (2001) Summary page 1.
- K953484: Pollux OA/Pollux 30A/Pollux 70A, Pollux Endoscopy, Inc. (1995) Summary page 1.

## Most influential descendants
- K130778: Discoscopes, Cervical Endoscopes (2014), 14 descendants of its own
- K180766: Endiscope, Endiscope Cervical (2018), 12 descendants of its own
- K201134: Arthrex NanoScope System (2020), 11 descendants of its own
- K243008: Arthrex NanoScope System (2025), 4 descendants of its own
- K223759: Arthrex SynergyID Endoscopic Imaging System (2023), 4 descendants of its own

## Indications for use
The Spinal Foraminoscope for lumbar access is indicated for endoscopic visualization in the lumbar region. The Spinal Foraminoscope for cervical access is indicated for visual inspection of the cervical spinal nerve root and tissue.

Source page: https://510kreport.com/device/K082841
Methodology: https://510kreport.com/methodology