510(k) K261098
K261098 is an FDA 510(k) premarket notification submitted by Senzime AB for the device "TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Senzime AB has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2026
- Date Received
- April 2, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Peripheral, Electric
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type