FDA Product Code PLL: Submucosal Injection Agent
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.
Leading manufacturers include The Standard Co., Ltd. and Ovesco Endoscopy AG.
FDA 510(k) Cleared Submucosal Injection Agent Devices (Product Code PLL)
About Product Code PLL - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PLL since 2015, with 9 receiving FDA clearance (average review time: 184 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under PLL have taken an average of 30 days to reach a decision - down from 203 days historically, suggesting improved FDA processing for this classification.
PLL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →