FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EverLift Submucosal Lifting Agent
K Number: K191923
·
Decision Jun 20, 2020
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
8
Review Days
338
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Basic Information
- Device Name
- EverLift Submucosal Lifting Agent
- K Number
- K191923
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gi Supply
- Date Received
- July 18, 2019
- Decision Date
- June 20, 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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LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
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Blue Beacon Submucosal Injectable Solution
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EverLift Submucosal Lifting Agent
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FDA Class 2
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EndoClot
FDA 510(k)
FDA Class 2
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Other Clearances by Gi Supply
| K Number | Device Name | ||
|---|---|---|---|
| K031360 | GI SUPPLY BILIARY STENT | Sep 24, 2003 | Substantially Equivalent |
| K012411 | HP-ONE | Sep 25, 2001 | Substantially Equivalent |
| K970187 | RUNYON LARGE VOLUME PARACENTESIS KIT | Feb 14, 1997 | Substantially Equivalent |
| K970186 | GI SUPPLY PARACENTESIS PUMP | Feb 14, 1997 | Substantially Equivalent |
| K944903 | HP-FAST | Apr 20, 1995 | Substantially Equivalent |
| K931044 | OXY-BLOC | Oct 4, 1993 | Substantially Equivalent |
| K915816 | BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY | Mar 27, 1992 | Substantially Equivalent |