InSure ONE
FDA 510(k) clearance K170548 · decided 2017-10-05
Clearance details
- K-number
- K170548
- Device name
- InSure ONE
- Applicant
- Enterix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-24
- Decision date
- 2017-10-05
- Days to decision
- 223 days
- Clearance type
- Traditional
- 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
| Record | Firm | Date |
|---|---|---|
| InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - recall (Z-0725-2026) | Enterix, Inc. | 2025-11-28 |