Submucosal Injection Agent

PLL · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500

Classification

FDA Product Code: PLL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.1500
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 13

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown