Data / Medical devices / United States / Inventex Medical
Inventex Medical: FDA-registered device maker in Niles, IL, United States, 6 510(k) clearances
Inventex Medical is registered with the FDA (registration 3009495876) in Niles, IL, United States. It lists 22 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009495876
- Address
- 7415 N Melvina Ave, Niles, IL, United States, 60714
- Owner or operator
- Inventex Medical (10040210)
- Roles
- Complaint file establishment, Contract manufacturer
- First device listed
- March 19, 2012
- Registered through
- 2026
- Brand names listed
- ZQuiet
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2022 | K213690 | Eclipse Blood Collection Set | JKA | Substantially Equivalent | Eclipse Medcorp, LLC | accessdata.fda.gov |
| August 6, 2019 | K191295 | Percutaneous Introducer Needle | GCJ | Substantially Equivalent | Progressive Medical, Inc. | accessdata.fda.gov |
| May 18, 2018 | K180259 | Sterile Hypodermic Needle for Single Use | FMI | Substantially Equivalent | Jiangsu Shenli Medical Production Co., Ltd. | accessdata.fda.gov |
| July 31, 2015 | K150068 | Unimicro Veress Needle | HIF | Substantially Equivalent | Unimicro Medical Systems (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| December 4, 2009 | K091672 | DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES | GEI | Substantially Equivalent | Shuyou Electric Medical Science Co., Ltd. | accessdata.fda.gov |
| February 10, 2005 | K040780 | ELECTROSURGICAL PENCILS | GEI | Substantially Equivalent | Hangzhou Shuyou Medical Instrument Company, Ltd. | accessdata.fda.gov |
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Updated October 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.