# K212164: Mapping Suction Probe

- Pathway: 510(k) (Traditional)
- Applicant: Inomed Medizintechnik GmbH
- Decided: Nov 11, 2022 after 487 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: 6 generations back to K980148 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110712: Drytouch Suction Stimulator Probe, Neurovision Medical Products, Inc. (2011) Summary page 4.

## Indications for use
The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument. The instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.

Source page: https://510kreport.com/device/K212164
Methodology: https://510kreport.com/methodology