Endoscopic Pancreatic Debridement Device

QNE · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.4330

Classification

FDA Product Code: QNE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.4330
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

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