InSure ONE— 510(k) K170548
Substantially EquivalentEnterix, Inc.
FDA 510(k) clearance K170548 for InSure ONE, Substantially Equivalent on 2017-10-05. Applicant: Enterix, Inc.. Device class: 2.
Clearance details
- Applicant
- Enterix, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code KHE
view allMore clearances from Enterix, Inc.
view allRecalls naming K170548
K-number listed on FDA's recall record- Z-0725-2026 — InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
- Z-0590-2021 — InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170548.
Data sourced from openFDA. This site is unofficial and independent of the FDA.