FDA Product Code
FDA Product Code PLL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260997 | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | Endoclot Plus Co., Ltd. | 2026-09-09 | Traditional | PDF ↗ |
| K241591 | Blue Eye | The Standard Co., Ltd. | 2024-07-03 | Special | PDF ↗ |
| K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | 2022-08-12 | Traditional | PDF ↗ |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | Ovesco Endoscopy AG | 2022-08-11 | Traditional | PDF ↗ |
| K200071 | Blue Beacon Submucosal Injectable Solution | Micro-Tech (Nanjing) Co., Ltd. | 2020-11-03 | Traditional | PDF ↗ |
| K202376 | EverLift Submucosal Lifting Agent | Gi Supply, Inc. | 2020-09-30 | Special | PDF ↗ |
| K191923 | EverLift Submucosal Lifting Agent | Gi Supply | 2020-06-20 | Traditional | PDF ↗ |
| K191254 | EndoClot | Endoclot Plus Co., Ltd. | 2020-01-30 | Traditional | PDF ↗ |
| K180068 | ORISE Gel | Boston Scientific | 2018-09-28 | Traditional | PDF ↗ |
| K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015-09-03 | Traditional | PDF ↗ |
Product code PLL · Class II · Gastroenterology, Urology. Data: openFDA.