21 CFR § 882.5500 Neurological Devices

§ 882.5500 Lesion temperature monitor.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(a) Identification. A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe.

(b) Classification. Class II (performance standards).

← § 882.5360 Cranioplasty plate fastener.§ 882.5550 Central nervous system fluid shunt and components. →