Endoscopic Morcellator Gastroenterology

PTE · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.1690

Classification

FDA Product Code: PTE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.1690
Review panel: GU
Medical specialty: Obstetrics/Gynecology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

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