Data / Medical devices / Submucosal Injection Agent
Submucosal Injection Agent (PLL): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Submucosal Injection Agent (product code PLL, Class 2, 21 CFR 876.1500). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on September 9, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- PLL
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| Germany | 2 |
| United States | 1 |
| South Korea | 1 |
| Ireland | 1 |
Makers of Submucosal Injection Agent
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gi Supply | Mechanicsburg, PA, United States | Manufacturer | 2 | September 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| The Standard Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 2 | July 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cosmo Technologies Ltd. | Dublin 2 Dublin(County), Ireland | Specification developer | 1 | September 3, 2015 | 0 | 0 | 0 | api.fda.gov |
| Endoclot Plus Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | January 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 1 | November 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 1 | November 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ovesco Endoscopy AG | Tuebingen Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | August 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Rommelag CDMO GmbH | Sulzbach-Laufen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.