Data / Medical devices / United States / Andersen Sterilizers, Inc.
Andersen Sterilizers, Inc.: FDA-registered device maker in Haw River, NC, United States, 19 510(k) clearances
Andersen Sterilizers, Inc. is registered with the FDA (registration 3004634710) in Haw River, NC, United States. It lists 4 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 12, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004634710
- Address
- 3154 Caroline Dr, Haw River, NC, United States, 27258
- Owner or operator
- Andersen Sterilizers (10051558)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 4, 2016
- Registered through
- 2026
- Brand names listed
- AN1087 Dosimeter, AN85/AN86 EO Indicators, AN87 Dosimeter, Anprolene AN75 Ethylene Oxide Sterilizer, Anprolene SteriTest, AN7508.14, Anprolene Steritest RRBI, EOGas 4 Endo-SteriTest, EOGas 4 Endo-SteriTest RRBI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | 2 | Specification developer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer | accessdata.fda.gov |
| Sterilizer, Ethylene-Oxide Gas | FLF | 2 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 12, 2022 | K213296 | Anprolene SteriTest RRBI | FRC | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| March 3, 2021 | K202879 | EOGas 4 Endo-SteriTest RRBI | FRC | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 12, 2020 | K200336 | Tyvek Sterilization Pouches with Chevron Seal | FRG | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 12, 2020 | K200335 | Sterisheet Sterilization Wrap | FRG | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 12, 2020 | K200334 | AN1036 Dosimeter | JOJ | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 12, 2020 | K192980 | EOGas 4 Endo-SteriTest | FRC | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 12, 2020 | K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | FLF | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 1, 2017 | K170439 | AN87 Dosimeter | JOJ | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 1, 2017 | K170437 | Sterisheet Sterilization Wrap | FRG | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| October 31, 2017 | K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | FLF | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| October 31, 2017 | K170427 | Anprolene SteriTest | FRC | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| October 30, 2017 | K170426 | AN85/AN86 EO Indicators | JOJ | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| October 27, 2017 | K170429 | Tyvek Sterilization Pouches with Chevron Seal | FRG | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| December 17, 2015 | K152291 | Sterisheet Sterilization Wrap | FRG | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 19, 2015 | K150645 | AN1087 Dosimeter | JOJ | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 18, 2015 | K152058 | Tyvek Sterilization Pouches with Chevron Seal | FRG | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 18, 2015 | K151585 | Andersen EOGas 4 SteriTest | FRC | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 18, 2015 | K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | FLF | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
| November 18, 2015 | K150644 | AN85/AN86 EO Indicators | JOJ | Substantially Equivalent | Andersen Sterilizers, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Biological Sterilization Process
- All makers of Sterilizer, Ethylene-Oxide Gas
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Wrap, Sterilization
Updated April 12, 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.