EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle— 510(k) K210476
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K210476 for EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle, Substantially Equivalent on 2021-05-20. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- 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
- Limerick, IE
Recent devices under product code FCG
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view all- K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more
- K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS) +4 more
- K230909 — EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- K213946 — Compass BDS Biliary Stent
- DEN180062 — EchoTip Insight Portosystemic Pressure Gradient Measuring System
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 K210476
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210476.
Data sourced from openFDA. This site is unofficial and independent of the FDA.