MD TECH BIOPSY SET FOR BONE AND BONE MARROW— 510(k) K980196

Clearance details

Applicant

Medical Device Technologies, Inc.

Product code

Code KNW

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

1998-01-20

Decision date

1998-02-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gainsville, FL, US

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• K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
• K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
• K260572 — Marrow Marxman2026-08-04
• K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

• K101832 — BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT2010-08-27
• K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR2006-01-26
• K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR2005-08-30
• K050873 — CANALIZER HYDROPHILIC GUIDE WIRE2005-05-26
• K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE2005-02-11

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 →

• Z-2706-2026 — General Biospy Tray, REF: GUTS1000Class I·Ongoing·Argon Medical Devices, Inc·20260601
• Z-2707-2026 — T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATLClass I·Ongoing·Argon Medical Devices, Inc·20260601
• Z-2709-2026 — Bone Marrow Tray, REF: CB0033TL; CB0355TLAClass I·Ongoing·Argon Medical Devices, Inc·20260601
• Z-1194-2017 — BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimensClass II·Terminated·Argon Medical Devices, Inc·20170118
• Z-1195-2017 — T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimensClass II·Terminated·Argon Medical Devices, Inc·20170118
• Z-1196-2017 — HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimensClass II·Terminated·Argon Medical Devices, Inc·20170118
• Z-2189-2015 — T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304Class II·Terminated·Argon Medical Devices, Inc·20150618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K980196.