FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
END 200 Endoscopic Tubeset
K Number: K202922
·
Decision Jul 8, 2021
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
6
Review Days
282
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Basic Information
- Device Name
- END 200 Endoscopic Tubeset
- K Number
- K202922
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Palliare , Ltd.
- Date Received
- September 29, 2020
- Decision Date
- July 8, 2021
- Product Code
- FCX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Palliare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232902 | EVA15 insufflator | May 2, 2024 | Substantially Equivalent |
| K230474 | EVA5 Insufflator | Mar 24, 2023 | Substantially Equivalent |
| K222901 | EVA15 insufflator | Jan 27, 2023 | Substantially Equivalent |
| K202799 | EVA15 | Oct 21, 2020 | Substantially Equivalent |
| K193520 | EVA 15 Insufflator | Jul 23, 2020 | Substantially Equivalent |