|
Device |
endoscopic tissue approximation device |
Definition |
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue. |
Product Code | OCW |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ANCHORA MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APOLLO ENDOSURGERY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
APOLLO ENDOSURGERY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APOLLO ENDOSURGERY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AXIOM TECHNOLOGY PARTNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAROSENSE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDO TOOLS THERAPEUTICS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOGASTRIC SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTH VALUE CREATION BV, TRADING AS CORPORIS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDEON BIODESIGN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDEON BIODESIGN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MINI LAP TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MINILAP TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRET SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUTUREEASE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
USGI MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Covidien LP |
II |
Feb-06-2024 |
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