← FDA Medical Device Classifications

Camera, Surgical, Measurement

SFG · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4160

Classification

FDA Product Code
SFG
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.4160
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

An adjunctive tool to measure and record a body part’s physical data, such as diameter, surface area, volume, and perimeter/circumference. The device does not provide a diagnosis or therapy.

Market data

Cleared 510(k) submissions
1
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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