FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
Steriking® Pouch for Robotic Instruments
K Number: K232625
·
Decision Jun 7, 2024
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
7
Review Days
283
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Basic Information
- Device Name
- Steriking® Pouch for Robotic Instruments
- K Number
- K232625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wipak OY
- Date Received
- August 29, 2023
- Decision Date
- June 7, 2024
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by Wipak OY
| K Number | Device Name | ||
|---|---|---|---|
| K231999 | Steriking® LT-Blueline Pouches with Tyvek® | Sep 7, 2023 | Substantially Equivalent |
| K231996 | Steriking® LT-Blueline Pouches with Tyvek® | Sep 7, 2023 | Substantially Equivalent |
| K221379 | Steriking LT-Blueline Pouches with Tyvek | Jan 4, 2023 | Substantially Equivalent |
| K221377 | SteriKing LT-Blueline Pouches with Tyvek | Dec 22, 2022 | Substantially Equivalent |
| K221016 | Steriking Packaging for Medical Devices | May 5, 2022 | Substantially Equivalent |
| K210810 | Steiking Packaging for Medical Devices | Jan 23, 2022 | Substantially Equivalent |