FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Blue Eye
K Number: K241591
·
Decision Jul 3, 2024
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- Blue Eye
- K Number
- K241591
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Standard Co., Ltd.
- Date Received
- June 3, 2024
- Decision Date
- July 3, 2024
- 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.
Blue Eye (TS-905)
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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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EverLift Submucosal Lifting Agent
FDA 510(k)
FDA Class 2
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EndoClot
FDA 510(k)
FDA Class 2
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Other Clearances by The Standard Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220434 | Blue Eye (TS-905) | Aug 12, 2022 | Substantially Equivalent |