System, Suction, Lipoplasty

MUU · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.5040

Classification

FDA Product Code: MUU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.5040
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).

Market data

Cleared 510(k) submissions: 40
Registered establishments: 41

Source

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