← FDA Medical Device Classifications

Suture, Nonabsorbable

GAO · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4495

Classification

FDA Product Code
GAO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4495
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Market data

Cleared 510(k) submissions
4
Registered establishments
18

Source

Authoritative
FDA Device Classification database
Machine
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