Stapler, Surgical

GAG · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 878.4740

Classification

FDA Product Code: GAG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4740
Review panel: SU
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Market data

Cleared 510(k) submissions: 42
Registered establishments: 77

Source

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