# K180315: Diskom

- Pathway: 510(k) (Traditional)
- Applicant: Biopsybell S.R.L.
- Decided: Mar 26, 2018 after 49 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: 3 generations back to K844131 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141557: Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy  Device - Lumbar, Gallini Medical Devices, Srl (2014) Summary page 4.
- K032473: Dekompressor Percutaneous Discectomy Probe, Stryker Instruments (2003) Summary page 4.

## Indications for use
The DISKOM is intended for use in aspiration of disc material during percutancous discectomics in the lumbar, thoracic and cervical regions of the spine

Source page: https://510kreport.com/device/K180315
Methodology: https://510kreport.com/methodology