510(k) K220434
- Device
- Blue Eye (TS-905)
- Applicant
- The Standard Co., Ltd.
- 510(k) number
- K220434
- Product code
- PLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-12
- Date received
- 2022-02-15
- Regulation
- 876.1500
- Classification name
- Submucosal Injection Agent
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sung Nam Kim
- Address
- 120, Gunpocheomdansaneop 2-Ro Gunpo-Si KR 15880 15880
FDA Registration Numbers#
- 3012099114
- 3008132411
- 3013155768
- 3006696607
- 3005099803
- 1528319
- 3013734919
- 3008720584
- 3013440400
- 3004837686
- 3014718111
- 9681630
- 3013911864
Source Documents#
Other 510(k) Records For Product Code PLL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241591 | Blue Eye | The Standard Co., Ltd. | 2024-07-03 |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | Ovesco Endoscopy AG | 2022-08-11 |
| K200071 | Blue Beacon Submucosal Injectable Solution | Micro-Tech (Nanjing) Co., Ltd. | 2020-11-03 |
| K202376 | EverLift Submucosal Lifting Agent | Gi Supply, Inc. | 2020-09-30 |
| K191923 | EverLift Submucosal Lifting Agent | Gi Supply | 2020-06-20 |
| K191254 | EndoClot | Endoclot Plus Co., Ltd. | 2020-01-30 |
| K180068 | ORISE Gel | Boston Scientific | 2018-09-28 |
| K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015-09-03 |
Legacy Summary#
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FDA Review#
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