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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | Boston Scientific Corporation ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, Open, Classified |
PLL | K180068 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.