Enterix, Inc.
Edison, NJ, US
ENTERIX INC. appears in FDA device records in Edison, NJ. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Enterix, Inc. between 2001 and 2017. The busiest year on record is 2001, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2006 | 1 |
| 2017 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1226769 | 3003224146 | ENTERIX INC. | 236 Fernwood Ave, EDISON, NJ 08837 US | 2026 | |
| 3005311019 | 3005311019 | ENTERIX PTY LTD. | UNIT 15/2 EDEN PARK DRIVE, NORTH RYDE New South Wales 2113 AU | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. | Class II | Open, Classified | |
| 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. | Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy | Class II | Terminated | |
| Z-0480-2009 | INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions. Product 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit. | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain