BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES— 510(k) K895725

Name: FDA 510(k) clearance K895725
Creator: U.S. Food and Drug Administration
Published: 1989-11-06

Substantially Equivalent

Interson Corp.

FDA 510(k) clearance K895725 for BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES, Substantially Equivalent on 1989-11-06. Applicant: Interson Corp.. Device class: 2.

Clearance details

Applicant: Interson Corp.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1989-09-25
Decision date: 1989-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Interson Corp.

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K911116 — INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST1991-12-20
K911113 — INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST1991-12-17
K911115 — INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM1991-12-17
K911117 — INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST1991-12-17
K911114 — INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM1991-11-19

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.