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., Endoclot Plus Co., Ltd. and Ovesco Endoscopy AG.

10
Total
10
Cleared
182d
Avg days
2015
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 167d avg (recent)

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

10 devices
1–10 of 10
Cleared Sep 09, 2026
SIS BLU (SISBLU-30-01)
K260997
Endoclot Plus Co., Ltd.
Gastroenterology & Urology · 167d
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
Cleared Sep 03, 2015
SIC 8000
K150852
Cosmo Technologies, Ltd.
Gastroenterology & Urology · 156d

About Product Code PLL - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code PLL since 2015, with 10 receiving FDA clearance (average review time: 182 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - PLL Product Code

FDA review times for PLL submissions have been consistent, averaging 167 days recently vs 184 days historically.

PLL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →