FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EverLift Submucosal Lifting Agent
K Number: K202376
·
Decision Sep 30, 2020
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
2
Review Days
41
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Basic Information
- Device Name
- EverLift Submucosal Lifting Agent
- K Number
- K202376
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gi Supply, Inc.
- Date Received
- August 20, 2020
- Decision Date
- September 30, 2020
- Product Code
- PLL
- 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 |
|---|---|---|---|
| PLL | Submucosal Injection Agent | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLL), ordered by most recent decision date.
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FDA Class 2
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Other Clearances by Gi Supply, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221042 | Renova RP Centesis Pump | Apr 19, 2023 | Substantially Equivalent |