CO-AXIAL INTRODUCER NEEDLE— 510(k) K022634

Name: FDA 510(k) clearance K022634
Creator: U.S. Food and Drug Administration
Published: 2002-11-06

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K022634 for CO-AXIAL INTRODUCER NEEDLE, Substantially Equivalent on 2002-11-06. Applicant: Promex, Inc.. Device class: 2.

Clearance details

Applicant: Promex, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2002-08-08
Decision date: 2002-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, IN, US

Download summary PDF View on FDA.gov ↗

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K023450 — BIOPSY SITE TISSUE MARKER DEVICE2002-12-19
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K011270 — AUTOMATED CORE BIOPSY DEVICE2001-06-22
K001132 — BONE BIOPSY NEEDLE2000-05-01
K994272 — AUTOMATED CORE BIOPSY DEVICE2000-01-07

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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 →

Recalls naming K022634

K-number listed on FDA's recall record

Z-1072-2021 — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,Class II·Terminated·Argon Medical Devices, Inc·20201210
Z-1073-2021 — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,Class II·Terminated·Argon Medical Devices, Inc·20201210
Z-1074-2021 — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,Class II·Terminated·Argon Medical Devices, Inc·20201210
Z-1075-2021 — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,Class II·Terminated·Argon Medical Devices, Inc·20201210
Z-1076-2021 — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,Class II·Terminated·Argon Medical Devices, Inc·20201210
Z-1077-2021 — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,Class II·Terminated·Argon Medical Devices, Inc·20201210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022634.

Data sourced from openFDA. This site is unofficial and independent of the FDA.