Clearance Summary
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) received FDA 510(k) clearance under submission number K261992, sponsored by Solventum US, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-09-25.
- Submission: K261992
- Applicant / Sponsor: Solventum US, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2026-09-25
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.