Data / Medical devices / United States / Emmy Medical, LLC
Emmy Medical, LLC: FDA-registered device maker in Weston, MA, United States, 3 510(k) clearances
Emmy Medical, LLC is registered with the FDA (registration 3010314836) in Weston, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 6, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010314836
- Address
- 84 Byron Rd, Weston, MA, United States, 02493
- Owner or operator
- Emmy Medical, LLC (10048747)
- Roles
- Specification developer
- First device listed
- February 23, 2015
- Registered through
- 2026
- Brand names listed
- Cystosure XL, Kohli Atraumatic Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Specification developer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | 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 |
|---|---|---|---|---|---|---|
| August 6, 2018 | K181346 | CystoSure Plus Catheter | EZL | Substantially Equivalent | Emmy Medical, LLC | accessdata.fda.gov |
| February 9, 2018 | K172422 | Kohli Urinary Drainage Catheter | EZL | Substantially Equivalent | Nellie Medical, LLC | accessdata.fda.gov |
| December 19, 2014 | K142194 | CytoSure Urinary Access System | FAJ | Substantially Equivalent | Emmy Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Catheter, Retention Type, Balloon
Updated August 6, 2018. 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.