Magnetic Surgical System

PNL · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4815

Classification

FDA Product Code: PNL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4815
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2. The device is intended for prescription use only.

Market data

Cleared 510(k) submissions: 8
Registered establishments: 4

Source

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