Atlas FDA

Beacon EUS Access System

FDA 510(k) clearance K180037 · decided 2018-04-26

Clearance details

K-number
K180037
Device name
Beacon EUS Access System
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2018-01-05
Decision date
2018-04-26
Days to decision
111 days
Clearance type
Traditional
Product code
FCG
Device class
2
Regulation number
876.1075
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic recall (Z-2768-2020)Covidien Llc2020-08-05
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic recall (Z-2769-2020)Covidien Llc2020-08-05

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