FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Blue Eye (TS-905)
K Number: K220434
·
Decision Aug 12, 2022
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
2
Review Days
178
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Blue Eye (TS-905)
- K Number
- K220434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Standard Co., Ltd.
- Date Received
- February 15, 2022
- Decision Date
- August 12, 2022
- 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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blue Beacon Submucosal Injectable Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EverLift Submucosal Lifting Agent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EverLift Submucosal Lifting Agent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EndoClot
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by The Standard Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241591 | Blue Eye | Jul 3, 2024 | Substantially Equivalent |