Data / Medical devices / United States / Summit Medical, Inc.
Summit Medical, Inc.: FDA-registered device maker in Franklin, MA, United States, 1 510(k) clearance
Summit Medical, Inc. is registered with the FDA (registration 1222637) in Franklin, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 5, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222637
- FEI number
- 1000120904
- Address
- 20 Addison Ave., Franklin, MA, United States, 02038
- Owner or operator
- SUMMIT MEDICAL, INC. (9002417)
- Roles
- Specification developer
- First device listed
- May 13, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tubing, Fluid Delivery | FPK | 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 |
|---|---|---|---|---|---|---|
| February 5, 1993 | K921450 | NON-INVASIVE TUBING | FPK | Substantially Equivalent | Specialty Medical Sales, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 5, 1993. 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.