Andersen Sterilizers, Inc.
Haw River, NC, US
Andersen Sterilizers, Inc. appears in FDA device records in Haw River, NC. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 19 510(k) clearances for Andersen Sterilizers, Inc. between 2015 and 2022. The busiest year on record is 2015, with 6. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 6 |
| 2017 | 6 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213296 | Anprolene SteriTest RRBI | FRC | Substantially Equivalent | |
| K202879 | EOGas 4 Endo-SteriTest RRBI | FRC | Substantially Equivalent | |
| K200336 | Tyvek Sterilization Pouches with Chevron Seal | FRG | Substantially Equivalent | |
| K200335 | Sterisheet Sterilization Wrap | FRG | Substantially Equivalent | |
| K200334 | AN1036 Dosimeter | JOJ | Substantially Equivalent | |
| K192980 | EOGas 4 Endo-SteriTest | FRC | Substantially Equivalent | |
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | FLF | Substantially Equivalent | |
| K170439 | AN87 Dosimeter | JOJ | Substantially Equivalent | |
| K170437 | Sterisheet Sterilization Wrap | FRG | Substantially Equivalent | |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | FLF | Substantially Equivalent | |
| K170427 | Anprolene SteriTest | FRC | Substantially Equivalent | |
| K170426 | AN85/AN86 EO Indicators | JOJ | Substantially Equivalent | |
| K170429 | Tyvek Sterilization Pouches with Chevron Seal | FRG | Substantially Equivalent | |
| K152291 | Sterisheet Sterilization Wrap | FRG | Substantially Equivalent | |
| K150645 | AN1087 Dosimeter | JOJ | Substantially Equivalent | |
| K152058 | Tyvek Sterilization Pouches with Chevron Seal | FRG | Substantially Equivalent | |
| K151585 | Andersen EOGas 4 SteriTest | FRC | Substantially Equivalent | |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | FLF | Substantially Equivalent | |
| K150644 | AN85/AN86 EO Indicators | JOJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004634710 | 3004634710 | Andersen Sterilizers, Inc. | 3154 Caroline Dr, Haw River, NC 27258 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain