PLLClass II

Submucosal Injection Agent

21 CFR 876.1500 / Gastroenterology, Urology

PLL is the FDA product code for Submucosal Injection Agent, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2024-07-03, and one recall.

Classification record

Product code: PLL
Device name: Submucosal Injection Agent
FDA definition: 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.
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 10
Ingested recalls: 1

Clearances, product code PLL

By decision year

10 clearances under product code PLL with a decision year between 2015 and 2026, 2020 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code PLL by decision year
Year	Clearances
2015	1
2018	1
2020	4
2022	2
2024	1
2026	1

Applicants with the most clearances

Product code PLL

Applicants holding the most 510(k) clearances under product code PLL
Applicant	Clearances
Gi Supply	2
The Standard Co., Ltd.	2
Boston Scientific Corporation	1
Cosmo Technologies Ltd.	1
Endoclot Plus Co., Ltd.	1
Endoclot Plus Co., Ltd.	1
Micro-Tech (Nanjing) Co., Ltd.	1
Ovesco Endoscopy AG	1

Companies listing this code with FDA

Companies whose registered establishments list this code