Beacon EUS Access System— 510(k) K180037
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K180037 for Beacon EUS Access System, Substantially Equivalent on 2018-04-26. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code FCG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K180037
K-number listed on FDA's recall record- Z-2768-2020 — Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
- Z-2769-2020 — Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180037.
Data sourced from openFDA. This site is unofficial and independent of the FDA.