Atlas FDA

EASY CORE BIOPSY SYSTEM

FDA 510(k) clearance K040893 · decided 2004-05-06

Clearance details

K-number
K040893
Device name
EASY CORE BIOPSY SYSTEM
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2004-04-06
Decision date
2004-05-06
Days to decision
30 days
Clearance type
Special
Product code
FCG
Device class
2
Regulation number
876.1075
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Natick,, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Sci recall (Z-0487-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0488-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0489-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Sci recall (Z-0490-2009)Boston Scientific Corp2009-01-12
Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scien recall (Z-0491-2009)Boston Scientific Corp2009-01-12
Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scien recall (Z-0492-2009)Boston Scientific Corp2009-01-12
Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scien recall (Z-0493-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0494-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston Sci recall (Z-0495-2009)Boston Scientific Corp2009-01-12
Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521, St recall (Z-0328-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, St recall (Z-0329-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-451, UPN M001434511, St recall (Z-0330-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531, Steri recall (Z-0331-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN M001434541, St recall (Z-0332-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-456, UPN M001434561, St recall (Z-0333-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571, St recall (Z-0334-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-458, UPN M001434581, St recall (Z-0335-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN M001434591, St recall (Z-0336-2009)Boston Scientific Corporation2008-11-28
Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-460, UPN M001434601, St recall (Z-0337-2009)Boston Scientific Corporation2008-11-28

PMA approvals by this applicant

RecordFirmDate
ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (N970003/S304)Boston Scientific Corp2025-12-19
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374)Boston Scientific Corp2025-12-18
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082)Boston Scientific Corp2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (N970003/S305)Boston Scientific Corp2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079)Boston Scientific Corp2025-12-15
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078)Boston Scientific Corp2025-12-15