Clearance Summary
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) received FDA 510(k) clearance under submission number K261098, sponsored by Senzime AB. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-05-22.
- Submission: K261098
- Applicant / Sponsor: Senzime AB
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 2026-05-22
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.