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Endoscope, Flexible

GCQ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500

Classification

FDA Product Code
GCQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.1500
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
5
Registered establishments
4

Source

Authoritative
FDA Device Classification database
Machine
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