510(k) K261890
K261890 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories, LLC for the device "52Fr ViSiGi LUX; 52Fr ViSiGi 3D®". The FDA issued a decision of Substantially Equivalent on Aug 14, 2026. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Boehringer Laboratories, LLC has 43 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 2026
- Date Received
- Jun 5, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)