Product code PLL

Device name

Submucosal Injection Agent

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1500

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset