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FGO · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.4680

Classification

FDA Product Code
FGO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.4680
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
19
Registered establishments
26

Source

Authoritative
FDA Device Classification database
Machine
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