510(k) K261992
K261992 is an FDA 510(k) premarket notification submitted by Solventum US, LLC for the device "3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)". The FDA issued a decision of Substantially Equivalent on Sep 25, 2026. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Solventum US, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2026
- Date Received
- Jun 15, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
- 510(k)