Intersect Ent.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Intersect Ent.” (first 2022, latest 2022), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 156 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 156 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intersect Ent. took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | 1 | 1 |
| OWO | Drug-Eluting Sinus Stent | 1 | 0 |
Review panels
Most recent Intersect Ent. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212774 | VenSure LightGuide | LRC | 2022-02-04 | 156 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100044 | PMA | PROPEL | 2011-08-11 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-10-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Intersect Ent. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04858802: A Clinical Evaluation of PROPEL® Contour Sinus Implant (Completed, started 2021-05-12)
- NCT03599271: A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND) (Completed, started 2018-06-12)
- NCT02880514: In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia (Completed, started 2016-08)
- NCT02266810: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus (Completed, started 2014-09)
- NCT02228720: Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia (Completed, started 2014-06)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intersect Systems, Inc. (21 510(k)s)
- Intersect Medical Products, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intersect Ent.?
FDA lists 1 510(k) clearance under the applicant name “Intersect Ent.” (first 2022, latest 2022), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intersect Ent.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intersect Ent. is 156 days.
Which FDA product codes appear under Intersect Ent.?
The most frequent FDA product codes under this applicant name are LRC (Instrument, Ent Manual Surgical, 1); OWO (Drug-Eluting Sinus Stent, 1).
Next steps
- See all 1 Intersect Ent. clearances with predicates and recalls
- Run predicate analysis for product code LRC, Intersect Ent.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.