Percutaneous Surgical Set With Attachments

OXT · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4805

Classification

FDA Product Code: OXT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4805
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.

Market data

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

Source

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