Data / Medical devices / United States / Thoracent LLC
Thoracent LLC: FDA-registered device maker in Huntington, NY, United States, 5 510(k) clearances
Thoracent LLC is registered with the FDA (registration 3013337852) in Huntington, NY, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 16, 2024. 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
- 3013337852
- Address
- 120 New York Ave Suite 6W, Huntington, NY, United States, 11743
- Owner or operator
- Thoracent LLC (10053873)
- Roles
- Complaint file establishment
- First device listed
- February 3, 2017
- Registered through
- 2026
- Brand names listed
- Bonastent Biliary, Bonastent Esophageal, Bonastent Tracheal, Croc-Bite Forceps, Hilzo Esophageal Stent, ITAFLEX - LOOP-NET, Pinza Forceps
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Forceps, Biopsy, Non-Electric | FCL | 1 | Complaint file establishment | accessdata.fda.gov |
| Prosthesis, Esophageal | ESW | 2 | Complaint file establishment | accessdata.fda.gov |
| Prosthesis, Tracheal, Expandable | JCT | 2 | Complaint file establishment | accessdata.fda.gov |
| Snare, Non-Electrical | FGX | 1 | Complaint file establishment | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Complaint file establishment | 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 16, 2024 | K223266 | Hilzo Esophageal Stents | ESW | Substantially Equivalent | Thoracent, Inc. | accessdata.fda.gov |
| October 17, 2014 | K140472 | BONASTENT TRACHEAL / BRONCHIAL | JCT | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
| June 16, 2014 | K140760 | BONASTENT BILIARY | FGE | Unknown | Endochoice, Inc. | accessdata.fda.gov |
| March 24, 2010 | K093003 | BONASTENT BILIARY | FGE | Unknown | Endochoice, Inc. | accessdata.fda.gov |
| February 22, 2010 | K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR | ESW | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Prosthesis, Esophageal
- All makers of Snare, Non-Electrical
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Prosthesis, Tracheal, Expandable
Updated January 16, 2024. 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.