Insure II
by Enterix Inc.
510(k) K060930
Insure II is a Class II device made by Enterix Inc., cleared under FDA 510(k) K060930 on 4 May 2006, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060930 | Date4 May 2006 | StatusActive |
Official records
- FDA 510(k) database K060930
Recalls
-
- Terminated Z-0480-2009
False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681.
Timeline
- Cleared FDA 510(k) K060930
- Recall initiated FDA recalls Z-0480-2009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KHE
- FDA applicant
- Enterix, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 864.6550
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
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