510(k) K253970
K253970 is an FDA 510(k) premarket notification submitted by Sensomedical Labs, Ltd. for the device "Wovyn Depth Electrode". The FDA issued a decision of Substantially Equivalent on April 17, 2026. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Sensomedical Labs, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2026
- Date Received
- December 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type