Data / Medical devices / Finland / Wipak OY
Wipak OY: FDA-registered device maker in NASTOLA Etela-Karjala, Finland, 10 510(k) clearances
Wipak OY is registered with the FDA (registration 9613277) in NASTOLA Etela-Karjala, Finland. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 7, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613277
- FEI number
- 3003756809
- Address
- Wipaktie 2, NASTOLA Etela-Karjala, Finland, FI 15561
- Owner or operator
- WIPAK OY (9035122)
- Roles
- Manufacturer
- First device listed
- February 21, 2008
- Registered through
- 2026
- Brand names listed
- STERIKING, See&Peel, Steriking
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | 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 |
|---|---|---|---|---|---|---|
| June 7, 2024 | K232625 | Steriking® Pouch for Robotic Instruments | FRG | Substantially Equivalent | Wipak OY | accessdata.fda.gov |
| September 7, 2023 | K231999 | Steriking® LT-Blueline Pouches with Tyvek® | FRG | Substantially Equivalent | Wipak OY | accessdata.fda.gov |
| September 7, 2023 | K231996 | Steriking® LT-Blueline Pouches with Tyvek® | FRG | Substantially Equivalent | Wipak OY | accessdata.fda.gov |
| January 4, 2023 | K221379 | Steriking LT-Blueline Pouches with Tyvek | FRG | Substantially Equivalent | Wipak OY | accessdata.fda.gov |
| December 22, 2022 | K221377 | SteriKing LT-Blueline Pouches with Tyvek | FRG | Substantially Equivalent | Wipak OY | accessdata.fda.gov |
| May 5, 2022 | K221016 | Steriking Packaging for Medical Devices | FRG | Substantially Equivalent | Wipak OY | accessdata.fda.gov |
| January 23, 2022 | K210810 | Steiking Packaging for Medical Devices | FRG | Substantially Equivalent | Wipak OY | accessdata.fda.gov |
| February 11, 1998 | K973827 | KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION | KCT | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 12, 1995 | K953776 | STERIKING STERILIZATION POUCHES & ROLLS | KCT | Substantially Equivalent | Wihuri OY | accessdata.fda.gov |
| January 28, 1981 | K803293 | GUARDIAN PEEL POUCHES | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Updated June 7, 2024. 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.