Entellus Medical, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Entellus Medical, Inc.” (first 2008, latest 2022), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 85 days. Since 2017 the median was 111 days, against 178 days for all cleared 510(k)s in the same product codes. 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 Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 30 |
| 2013 | 3 | 59 |
| 2014 | 2 | 44 |
| 2015 | 2 | 85 |
| 2016 | 0 | — |
| 2017 | 2 | 115 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 97 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Entellus Medical, Inc. took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | 21 | 21 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| PNZ | Eustachian Tube Balloon Dilation Device | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- Ear, Nose and Throat (25)
- Anesthesiology (1)
- General Hospital (1)
Most recent Entellus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220027 | Audion ET dilation system | PNZ | 2022-04-12 | 97 |
| K163509 | XprESS ENT Dilation System | PNZ | 2017-04-05 | 111 |
| K163435 | Entellus Medical Reinforced Anesthesia Needle | BSP | 2017-04-05 | 119 |
| K152435 | PassAssist LED Light Fiber | LRC | 2015-11-20 | 85 |
| K152434 | XprESS Multi-Sinus Dilation System | LRC | 2015-11-20 | 85 |
| K142252 | XprESS Multi-Sinus Dilation Tool | LRC | 2014-10-17 | 64 |
| K141916 | PATHASSIST LED LIGHT FIBER | LRC | 2014-08-07 | 23 |
| K133563 | PATHASSIST LIGHT SEEKER | LRC | 2013-12-20 | 30 |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | LRC | 2013-10-04 | 59 |
| K130503 | PATHASSIST LED LIGHT FIBER | LRC | 2013-06-11 | 104 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Entellus Medical, Inc..
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 Entellus Medical, Inc. is the lead sponsor of 10 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04136977: XprESS ET Registry (Completed, started 2018-06-05)
- NCT02391584: XprESS Eustachian Tube Dilation Study (Completed, started 2015-02)
- NCT02278484: Sinus Balloon Dilation in Pediatric Patients (Completed, started 2014-09)
- NCT01612780: Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study (Completed, started 2012-04)
- NCT01525862: XprESS Maxillary Balloon Dilation Study (Completed, started 2011-12)
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.
- Entellus Medical, Inc. (Aka Stryker Ent) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Entellus Medical, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Entellus Medical, Inc.” (first 2008, latest 2022), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Entellus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Entellus Medical, Inc. is 85 days. Since 2017: 111 days, versus 178 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Entellus Medical, Inc.?
The most frequent FDA product codes under this applicant name are LRC (Instrument, Ent Manual Surgical, 21); EOB (Nasopharyngoscope (Flexible Or Rigid), 2); PNZ (Eustachian Tube Balloon Dilation Device, 2).
Next steps
- See all 27 Entellus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRC, Entellus Medical, Inc.'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.