Data / Medical devices / United States / Tangent Endoscopy, LLC
Tangent Endoscopy, LLC: FDA-registered device maker in Camden, DE, United States, 1 510(k) clearance
Tangent Endoscopy, LLC is registered with the FDA (registration 3041659934) in Camden, DE, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3041659934
- Address
- 2140 S Dupont Hwy, Camden, DE, United States, 19934
- Owner or operator
- Tangent Endoscopy, LLC (10094122)
- Roles
- Specification developer
- First device listed
- November 16, 2025
- Registered through
- 2026
- Brand names listed
- Tangent Digital Catheter, Tangent Digital Catheter System, Tangent Digital Controller
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Choledochoscope And Accessories, Flexible/Rigid | FBN | 2 | Specification developer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Specification developer | accessdata.fda.gov |
| Led Light Source | NTN | 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 |
|---|---|---|---|---|---|---|
| September 12, 2025 | K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | FBN | Substantially Equivalent | Tangent Endoscopy, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 23, 2026 | 98654 | Class II | Ongoing | Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk. | Affected devices exhibited fractures at the distal shaft tip without complete detachment. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Led Light Source
- All makers of Choledochoscope And Accessories, Flexible/Rigid
Updated May 15, 2026. 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.