Blue Eye
FDA 510(k) clearance K241591 · decided 2024-07-03
Clearance details
- K-number
- K241591
- Device name
- Blue Eye
- Applicant
- The Standard Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-03
- Decision date
- 2024-07-03
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- PLL
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gunpo-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Blue Eye (TS-905) (K220434) | The Standard Co., Ltd. | 2022-08-12 |
| LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (K221385) | Ovesco Endoscopy AG | 2022-08-11 |
| Blue Beacon Submucosal Injectable Solution (K200071) | Micro-Tech (Nanjing) Co., Ltd. | 2020-11-03 |
| EverLift Submucosal Lifting Agent (K202376) | Gi Supply, Inc. | 2020-09-30 |
| EverLift Submucosal Lifting Agent (K191923) | Gi Supply | 2020-06-20 |
| EndoClot (K191254) | Endoclot Plus Co., Ltd. | 2020-01-30 |
| ORISE Gel (K180068) | Boston Scientific | 2018-09-28 |
| SIC 8000 (K150852) | Cosmo Technologies, Ltd. | 2015-09-03 |
Recalls involving this device
No recalls on record reference this clearance.