Data / Medical devices / United States / Spirus Medical, LLC
Spirus Medical, LLC: FDA-registered device maker in W Bridgewater, MA, United States, 5 510(k) clearances
Spirus Medical, LLC is registered with the FDA (registration 3005814162) in W Bridgewater, MA, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 6, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005814162
- Address
- 375 West St, W Bridgewater, MA, United States, 02379
- Owner or operator
- Spirus Medical, LLC (10022943)
- Roles
- Specification developer
- First device listed
- October 24, 2007
- Registered through
- 2026
- Brand names listed
- Endo-Ease Advantage, Endo-Ease Discovery SB, Endo-Ease Vista, Spirus Medical Lubricant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Specification developer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Specification developer | accessdata.fda.gov |
| Enteroscope And Accessories | FDA | 2 | Specification developer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 6, 2008 | K080050 | SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE | FED | Substantially Equivalent | Spirus Medical, Inc. | accessdata.fda.gov |
| April 3, 2008 | K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | KMJ | Substantially Equivalent | Spirus Medical, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062805 | MODIFICATION TO ENDO-EASE | FED | Substantially Equivalent | Spirus Medical, Inc. | accessdata.fda.gov |
| August 4, 2006 | K060235 | ENDO-EASE ENDOSCOPIC OVERTUBE | FDA | Substantially Equivalent | Spirus Medical, Inc. | accessdata.fda.gov |
| September 14, 2005 | K052084 | ENDO-EASE ENDOSCOPIC OVERTUBE | FED | Substantially Equivalent | Spirus Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Patient
- All makers of Enteroscope And Accessories
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Colonoscope And Accessories, Flexible/Rigid
Updated May 6, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.