Atlas FDA

MODULAR TROCAR SYSTEM

FDA 510(k) clearance K060096 · decided 2006-01-24

Clearance details

K-number
K060096
Device name
MODULAR TROCAR SYSTEM
Applicant
Applied Medical Resources Corp.
Decision
Substantially Equivalent
Date received
2006-01-13
Decision date
2006-01-24
Days to decision
11 days
Clearance type
Traditional
Product code
GCJ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Rancho Santa, CA, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 recall (Z-1010-2026)Applied Medical Resources Corp2026-01-02
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optic recall (Z-2533-2017)Applied Medical Resources Corp2017-06-14
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36 Prod recall (Z-3066-2011)Applied Medical Resources Corp2011-08-24
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37 Prod recall (Z-3067-2011)Applied Medical Resources Corp2011-08-24
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38 Prod recall (Z-3068-2011)Applied Medical Resources Corp2011-08-24
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39 Prod recall (Z-3069-2011)Applied Medical Resources Corp2011-08-24
Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R3 recall (Z-2226-2009)Applied Medical Resources Corp2009-09-18