Panels › Gastroenterology, Urology › Product code PLL · Class 2
Submucosal Injection Agent
Regulation 876.1500
1510(k)s in 12 months (10 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PLL
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 1 | 1 |
| Endoclot Plus Co., Ltd. | 2 | 0 |
| Gi Supply | 2 | 0 |
| The Standard Co., Ltd. | 2 | 0 |
| Cosmo Technologies, Ltd. | 1 | 0 |
| Micro-Tech (Nanjing) Co., Ltd. | 1 | 0 |
| Ovesco Endoscopy AG | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2026 | K260997 | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) Endoclot Plus Co., Ltd., CN | PLL |
| Jul 3, 2024 | K241591 | Blue Eye The Standard Co., Ltd., KR | PLL |
| Aug 12, 2022 | K220434 | Blue Eye (TS-905) The Standard Co., Ltd., KR | PLL |
| Aug 11, 2022 | K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) Ovesco Endoscopy AG, DE | PLL |
| Nov 3, 2020 | K200071 | Blue Beacon Submucosal Injectable Solution Micro-Tech (Nanjing) Co., Ltd., CN | PLL |
| Sep 30, 2020 | K202376 | EverLift Submucosal Lifting Agent Gi Supply, Inc. | PLL |
| Jun 20, 2020 | K191923 | EverLift Submucosal Lifting Agent Gi Supply | PLL |
| Jan 30, 2020 | K191254 | EndoClot Endoclot Plus Co., Ltd., CN | PLL |
| Sep 28, 2018 | K180068 | ORISE Gel Boston Scientific | PLL |
| Sep 3, 2015 | K150852 | SIC 8000 Cosmo Technologies, Ltd., IE | PLL |
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