Data / Medical devices / United States / Amcor Flexibles, LLC
Amcor Flexibles, LLC: FDA-registered device maker in Mundelein, IL, United States, 3 510(k) clearances
Amcor Flexibles, LLC is registered with the FDA (registration 1418005) in Mundelein, IL, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 15, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1418005
- FEI number
- 3003243311
- Address
- 1919 S Butterfield Rd, Mundelein, IL, United States, 60060
- Owner or operator
- Amcor Flexibles (9059465)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 7, 2013
- Registered through
- 2026
- Brand names listed
- TYVEK Pouch/Roll with STERRAD Chemical Indicator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
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 15, 2012 | K112087 | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS | KCT | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| June 6, 2011 | K103210 | TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS | FRG | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
| May 19, 1995 | K951295 | STERRAD STERILIZATION POUCH | KCT | Substantially Equivalent | Advanced Sterilization Products | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Wrap, Sterilization
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated October 15, 2012. 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.