Atlas FDA

Cool-tip RF Ablation System E Series

FDA 510(k) clearance K203150 · decided 2022-02-25

Clearance details

K-number
K203150
Device name
Cool-tip RF Ablation System E Series
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2020-10-22
Decision date
2022-02-25
Days to decision
491 days
Clearance type
Traditional
Product code
GEI
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18