ECHO STAR NEEDLE SET— 510(k) K945921

Name: FDA 510(k) clearance K945921
Creator: U.S. Food and Drug Administration
Published: 1995-02-01

Substantially Equivalent

Ideamatrix

FDA 510(k) clearance K945921 for ECHO STAR NEEDLE SET, Substantially Equivalent on 1995-02-01. Applicant: Ideamatrix. Device class: 2.

Clearance details

Applicant: Ideamatrix
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1994-12-05
Decision date: 1995-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Estes Park, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCG

view all

K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)2025-10-24
K250994 — ClearTip FNA and FNB Types2025-08-21
K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)2024-07-29
K231422 — Precision GI2023-08-28
K231267 — ClearTip2023-06-30

More clearances from Ideamatrix

view all

K943368 — TRU-CORE NEEDLE SET1994-07-29

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.