FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
EVA15 insufflator
K Number: K232902
·
Decision May 2, 2024
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
6
Review Days
227
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Basic Information
- Device Name
- EVA15 insufflator
- K Number
- K232902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Palliare , Ltd.
- Date Received
- September 18, 2023
- Decision Date
- May 2, 2024
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Palliare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230474 | EVA5 Insufflator | Mar 24, 2023 | Substantially Equivalent |
| K222901 | EVA15 insufflator | Jan 27, 2023 | Substantially Equivalent |
| K202922 | END 200 Endoscopic Tubeset | Jul 8, 2021 | Substantially Equivalent |
| K202799 | EVA15 | Oct 21, 2020 | Substantially Equivalent |
| K193520 | EVA 15 Insufflator | Jul 23, 2020 | Substantially Equivalent |