Data / Medical devices / United States / Polygon Medical, Inc.
Polygon Medical, Inc.: FDA-registered device maker in Manalapan, NJ, United States, 1 510(k) clearance
Polygon Medical, Inc. is registered with the FDA (registration 3014407293) in Manalapan, NJ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 4, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014407293
- Address
- 19 Ashlynn Ct, Manalapan, NJ, United States, 07726
- Owner or operator
- Polygon Medical, Inc. (10056693)
- Roles
- Specification developer
- First device listed
- January 29, 2019
- Registered through
- 2026
- Brand names listed
- Polygon Resection Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | 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 |
|---|---|---|---|---|---|---|
| January 4, 2019 | K182675 | Polygon Resection Device | HIH | Substantially Equivalent | Polygon Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 4, 2019. 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.