Atlas FDA

ACCUMESH DEPLOYMENT SYSTEM

FDA 510(k) clearance K130782 · decided 2013-04-05

Clearance details

K-number
K130782
Device name
ACCUMESH DEPLOYMENT SYSTEM
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2013-03-21
Decision date
2013-04-05
Days to decision
15 days
Clearance type
Special
Product code
ORQ
Device class
2
Regulation number
878.3300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Bedford, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BioBrace ® RC Delivery System (K250395)Conmed Corporation2025-04-07
ACCUMESH DEPLOYMENT SYSTEM (K123066)Covidien, LLC2012-10-16
ACCUMESH DEPLOYMENT SYSTEM (K121139)Covidien, LLC2012-05-02
PATCHASSIST LARGE (K103269)Polytouch Medical, Ltd.2010-11-23
PATCHASSIST (K101218)Polytouch Medical, Ltd.2010-06-17

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