Intersect ENT, Inc.
FDA Regulatory Profile
Intersect ENT, Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0167-2023, Class III) was initiated on January 4, 2023. Its most recent 510(k) clearance was granted on February 4, 2022.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0167-2023 | Class III | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 15 | January 4, 2023 |
| Z-0458-2023 | Class II | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 | October 21, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212774 | VenSure LightGuide | February 4, 2022 |