Atlas FDA

WILSON-COOK BIPOLAR PROBE

FDA 510(k) clearance K990145 · decided 1999-03-25

Clearance details

K-number
K990145
Device name
WILSON-COOK BIPOLAR PROBE
Applicant
Wilson-Cook Medical, Inc.
Decision
Substantially Equivalent
Date received
1999-01-19
Decision date
1999-03-25
Days to decision
65 days
Clearance type
Traditional
Product code
KNS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Winston-Salem, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * C recall (Z-0699-05)Wilson-Cook Medical Inc2005-04-08