TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE— 510(k) K954265

Name: FDA 510(k) clearance K954265
Creator: U.S. Food and Drug Administration
Published: 1995-09-29

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K954265 for TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE, Substantially Equivalent on 1995-09-29. Applicant: Promex, Inc.. Device class: 2.

Clearance details

Applicant: Promex, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1995-09-12
Decision date: 1995-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Promex, Inc.

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K023450 — BIOPSY SITE TISSUE MARKER DEVICE2002-12-19
K022634 — CO-AXIAL INTRODUCER NEEDLE2002-11-06
K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE2001-07-24
K011270 — AUTOMATED CORE BIOPSY DEVICE2001-06-22
K001132 — BONE BIOPSY NEEDLE2000-05-01

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.