Atlas FDA

INSURE II

FDA 510(k) clearance K060930 · decided 2006-05-04

Clearance details

K-number
K060930
Device name
INSURE II
Applicant
Enterix, Inc.
Decision
Substantially Equivalent
Date received
2006-04-05
Decision date
2006-05-04
Days to decision
29 days
Clearance type
Special
Product code
KHE
Device class
2
Regulation number
864.6550
Medical specialty
Hematology
Advisory committee
Hematology
Location
Edison, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Qui recall (Z-0480-2009)Enterix, Inc.2008-12-29