PLL
9 FDA 510(k) clearances · Product code
178 daysmedian time to decision
338 days90th percentile
9clearances measured
FDA profile
- Official device name
- Submucosal Injection Agent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
- Adverse events (MAUDE)
- 2022: 36 · 2023: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Blue Eye (K241591) | The Standard Co., Ltd. | 2024-07-03 |
| 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 |
Track PLL automatically
Every clearance here is in the API, with alerts when new ones post.