Spirus Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spirus Medical, Inc.” (first 2005, latest 2008), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 3 | 3 |
| FDA | Enteroscope And Accessories | 1 | 1 |
| KMJ | Lubricant, Patient | 1 | 1 |
Review panels
Most recent Spirus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080050 | SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE | FED | 2008-05-06 | 119 |
| K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | KMJ | 2008-04-03 | 86 |
| K062805 | MODIFICATION TO ENDO-EASE | FED | 2006-10-13 | 24 |
| K060235 | ENDO-EASE ENDOSCOPIC OVERTUBE | FDA | 2006-08-04 | 186 |
| K052084 | ENDO-EASE ENDOSCOPIC OVERTUBE | FED | 2005-09-14 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Spirus 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Spirus Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Spirus Medical, Inc.” (first 2005, latest 2008), across 3 product codes in 2 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 Spirus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spirus Medical, Inc. is 86 days.
Which FDA product codes appear under Spirus Medical, Inc.?
The most frequent FDA product codes under this applicant name are FED (Endoscopic Access Overtube, Gastroenterology-Urology, 3); FDA (Enteroscope And Accessories, 1); KMJ (Lubricant, Patient, 1).
Next steps
- See all 5 Spirus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FED, Spirus 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.