PLL — Submucosal Injection Agent Class II
FDA product code PLL covers "Submucosal Injection Agent", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLL
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260997 | endoclot plus co | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | September 9, 2026 |
| K241591 | standard co | Blue Eye | July 3, 2024 |
| K220434 | standard co | Blue Eye (TS-905) | August 12, 2022 |
| K221385 | ovesco endoscopy | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | August 11, 2022 |
| K200071 | micro-tech (nanjing) co | Blue Beacon Submucosal Injectable Solution | November 3, 2020 |
| K202376 | gi supply | EverLift Submucosal Lifting Agent | September 30, 2020 |
| K191923 | gi supply | EverLift Submucosal Lifting Agent | June 20, 2020 |
| K191254 | endoclot plus co | EndoClot | January 30, 2020 |
| K180068 | boston scientific | ORISE Gel | September 28, 2018 |
| K150852 | cosmo technologies | SIC 8000 | September 3, 2015 |