Atlas FDA

GYRUS ACMI BICOAG HEMOSTASIS PROBE

FDA 510(k) clearance K123319 · decided 2012-12-14

Clearance details

K-number
K123319
Device name
GYRUS ACMI BICOAG HEMOSTASIS PROBE
Applicant
Olympus Surgical Technologies America
Decision
Substantially Equivalent
Date received
2012-10-26
Decision date
2012-12-14
Days to decision
49 days
Clearance type
Special
Product code
KNS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Southborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hemostasis Probe, Model: CD-B622LA recall (Z-1481-2024)Olympus Corporation of the Americas2024-04-05