510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103813Substantially Equivalent

Sopro 281

Sopro, Mt. Laurel NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K103813 is the FDA 510(k) clearance record for SOPRO 281, a class II device, cleared for Sopro on under FDA product code NTN (Led Light Source). FDA's definition for product code NTN reads: "Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals". FDA records list 9 510(k) clearances for Sopro, from to . As of , FDA records show no recalls naming K103813.

Clearance record

Decision date
Received
(83 days to decision)
Product code
NTN Led Light Source
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sopro 124 Gaither Dr. Suite #140, Mt. Laurel NJ
510(k) summary
Statement
Third party review
No

Clearances, product code NTN

Trailing 12 months

FDA records hold no clearances under product code NTN in the trailing twelve months.

FDA records show no clearances under product code NTN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260