ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.— 510(k) K882549

Name: FDA 510(k) clearance K882549
Creator: U.S. Food and Drug Administration
Published: 1988-07-21

Substantially Equivalent

Acuson Corp.

FDA 510(k) clearance K882549 for ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI., Substantially Equivalent on 1988-07-21. Applicant: Acuson Corp.. Device class: 2.

Clearance details

Applicant: Acuson Corp.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1988-06-20
Decision date: 1988-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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 Acuson Corp.

view all

K023772 — KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM2002-11-22
K022896 — CSV12 SOFTWARE VIEWER2002-10-03
K022567 — SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM2002-08-13
K021497 — CYPRESS ULTRASOUND SYSTEM2002-07-09
K010950 — CYPRESS SYSTEM2001-06-27

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.