# K233001: Bioscope Neuromonitor Device

- Pathway: 510(k) (Traditional)
- Applicant: Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
- Decided: Dec 13, 2024 after 448 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- 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 K923056 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083242: Neurosign Avalanche Motor Nerve Monitor, The Magstim Company, Ltd. (2009) Summary page 5.

## Indications for use
The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves. Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.

Source page: https://510kreport.com/device/K233001
Methodology: https://510kreport.com/methodology