510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFGClass I

Camera, Surgical, Measurement

21 CFR 878.4160 / General, Plastic Surgery
FDA source (opens on fda.gov)

SFG is the FDA product code for Camera, Surgical, Measurement, a class I device type, regulated under 21 CFR 878.4160. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SFG
Device name
Camera, Surgical, Measurement
FDA 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.
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SFG

By decision year
1 clearance under product code SFG with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFG by decision year
YearClearances
20251

Applicants with the most clearances

Product code SFG
Applicants holding the most 510(k) clearances under product code SFG
ApplicantClearances
Lymphatech1

Companies listing this code with FDA

Companies whose registered establishments list this code