Septal Stapler/Absorbable Staples

OLL · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4750

Classification

FDA Product Code: OLL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4750
Review panel: EN
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 8

Source

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