PLL · Class II · 21 CFR 876.1500

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., Boston Scientific and Endoclot Plus Co., Ltd..

9
Total
9
Cleared
184d
Avg days
2015
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Submucosal Injection Agent Devices (Product Code PLL)

9 devices
1–9 of 9
Cleared Jul 03, 2024
Blue Eye
K241591
The Standard Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Aug 12, 2022
Blue Eye (TS-905)
K220434
The Standard Co., Ltd.
Gastroenterology & Urology · 178d
Cleared Aug 11, 2022
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
K221385
Ovesco Endoscopy AG
Gastroenterology & Urology · 90d
Cleared Nov 03, 2020
Blue Beacon Submucosal Injectable Solution
K200071
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 295d
Cleared Sep 30, 2020
EverLift Submucosal Lifting Agent
K202376
Gi Supply, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 20, 2020
EverLift Submucosal Lifting Agent
K191923
Gi Supply
Gastroenterology & Urology · 338d
Cleared Jan 30, 2020
EndoClot
K191254
Endoclot Plus Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Sep 28, 2018
ORISE Gel
K180068
Boston Scientific
Gastroenterology & Urology · 262d

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 - 0 submissions in the last 24 months compared to 3 in the prior period.