510(k) Report

FDA applicant

Tangent Endoscopy, LLC

Camden, DE1 decision2025–20251 recall

FDA records 1 decision for Tangent Endoscopy, LLC (Camden, DE) in 2025: 1 510(k) clearance. All are in product code FBN (Choledochoscope And Accessories, Flexible/Rigid). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Tangent Endoscopy, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2025high 1 (2026) · low 0 (2025)2026

Class I Class II/III not classified

FIG. 1 — Tangent Endoscopy, LLC by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Tangent”

FDA records each applicant name separately; these may or may not be the same firm.