Mapping Suction Probe
510(k) K212164
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212164 | Date11 Nov 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ETN
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1820
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
A Mapping Suction Probe is a nerve stimulator device used for continuous mapping in ear, nose, and throat procedures. It is a monopolar probe with an isolated active tip of 2 mm, designed for use with a connecting cable and neutral electrode.
The device is supplied as a single-use product, ethylene oxide (EO) sterilized, and is available in various configurations including work lengths of 90 mm, 120 mm, and 130 mm, with corresponding total lengths and lumen sizes. It features a red connecting cable, black neutral electrode, and a cable length of 3000 mm. Authorization is based on FDA 510(k) clearance under product code ETN and regulation number 874.1820.
Other devices from inomed Medizintechnik GmbH
Questions
AI-generated answers, 22 Sep 2026
What is the Mapping Suction Probe used for?
The Mapping Suction Probe is a nerve stimulator device used for continuous mapping during ear, nose, and throat procedures. It delivers stimulation through its monopolar active tip to identify and map nerves in real time, helping surgeons avoid nerve injury during dissection or resection.
How is the Mapping Suction Probe supplied and sterilized?
The device is supplied as a single-use product and is sterilized using ethylene oxide (EO). This ensures it is free from microbial contamination before use, and it is intended for one-time application only to prevent cross-contamination and maintain performance integrity.
What are the key physical specifications of the Mapping Suction Probe?
The probe features an isolated active tip of 2 mm diameter and is available in work lengths of 90 mm, 120 mm, and 130 mm. It includes a red connecting cable, a black neutral electrode, and has a total cable length of 3000 mm, designed for compatibility with standard nerve monitoring systems in ENT surgery.