ClearanceBrief
510(k) K980196 ยท KNW Instrument, Biopsy

MD TECH BIOPSY SET FOR BONE AND BONE MARROW

ApplicantMedical Device Technologies, Inc., Gainsville FL, US
DecisionSubstantially Equivalent, Feb 3, 1998
ReceivedJan 20, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K980196

DateFirm and productCodeLinked 510(k)
Jul 10, 2026Argon Medical Devices, Inc
General Biospy Tray, REF: GUTS1000
Open, Classified
KNWNone listed
Jul 10, 2026Argon Medical Devices, Inc
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Open, Classified
KNWNone listed
Jul 10, 2026Argon Medical Devices, Inc
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Open, Classified
KNWNone listed
Feb 13, 2017Argon Medical Devices, Inc
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 specimens
Terminated
KNWNone listed
Feb 13, 2017Argon Medical Devices, Inc
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 specimens
Terminated
KNWNone listed
Feb 13, 2017Argon Medical Devices, Inc
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
Terminated
KNWNone listed
Jul 21, 2015Argon Medical Devices, Inc
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 DBMNJ1
Terminated
KNWNone listed
Jul 13, 2010Medical Device Technologies, Inc.
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesvil
Terminated
KNWNone listed
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister pack. Packaged 10 per box. Sterile.
Terminated
KNWNone listed
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
Terminated
KNWNone listed
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
Terminated
KNWNone listed
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is intended for use Bone Marrow Biopsy.
Terminated
KNWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.