510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973798Substantially Equivalent

S-357 Video Imaging System

Sopro, Marseille, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973798 is the FDA 510(k) clearance record for S-357 VIDEO IMAGING SYSTEM, a class II device, cleared for Sopro on under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology). FDA's definition for product code FET reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". FDA records list 15 510(k) clearances for Sopro, from to . As of , FDA records show no recalls naming K973798.

Clearance record

Decision date
Received
(58 days to decision)
Product code
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sopro Pl. St. Christophe, Marseille, FR
510(k) summary
Summary
Third party review
No

Clearances, product code FET

Trailing 12 months
3 clearances under product code FET in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FET, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260