Atlas FDA

MD TECH BIOPSY SET FOR BONE AND BONE MARROW

FDA 510(k) clearance K980196 · decided 1998-02-03

Clearance details

K-number
K980196
Device name
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
Applicant
Medical Device Technologies, Inc.
Decision
Substantially Equivalent
Date received
1998-01-20
Decision date
1998-02-03
Days to decision
14 days
Clearance type
Traditional
Product code
KNW
Device class
2
Regulation number
876.1075
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Gainsville, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
General Biospy Tray, REF: GUTS1000 recall (Z-2706-2026)Argon Medical Devices, Inc2026-07-10
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL recall (Z-2707-2026)Argon Medical Devices, Inc2026-07-10
Bone Marrow Tray, REF: CB0033TL; CB0355TLA recall (Z-2709-2026)Argon Medical Devices, Inc2026-07-10
BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of recall (Z-1194-2017)Argon Medical Devices, Inc2017-02-13
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EX recall (Z-1195-2017)Argon Medical Devices, Inc2017-02-13
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow spe recall (Z-1196-2017)Argon Medical Devices, Inc2017-02-13
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow recall (Z-2189-2015)Argon Medical Devices, Inc2015-07-21
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Num recall (Z-2019-2010)Medical Device Technologies, Inc.2010-07-13
Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual pac recall (Z-0450-2009)Medical Device Technologies, Inc.2009-01-06
Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is inte recall (Z-0451-2009)Medical Device Technologies, Inc.2009-01-06
Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device i recall (Z-0452-2009)Medical Device Technologies, Inc.2009-01-06
Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is int recall (Z-0453-2009)Medical Device Technologies, Inc.2009-01-06