EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)— 510(k) K241209
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K241209 for EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19), Substantially Equivalent on 2024-07-29. 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
view allMore clearances from Cook Ireland, Ltd.
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
- K213946 — Compass BDS Biliary Stent
- K210476 — 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
- 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.