510(k) K260181
K260181 is an FDA 510(k) premarket notification submitted by Intertape Polymer Group for the device "LF Process Indicator Tape for Steam Sterilization". The FDA issued a decision of Substantially Equivalent on February 20, 2026. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2026
- Date Received
- January 21, 2026
- Clearance Type
- Special
- 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