510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993951Substantially Equivalent

Spot Endoscopic Marker

Chek-Med Systems, Willington CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993951 is the FDA 510(k) clearance record for SPOT ENDOSCOPIC MARKER, a class II device, cleared for Chek-Med Systems on under FDA product code NBG (Marker, Colon). FDA records list 3 510(k) clearances for Chek-Med Systems, from to . As of , FDA records show no recalls naming K993951.

Clearance record

Decision date
Received
(88 days to decision)
Product code
NBG Marker, Colon
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Chek-Med Systems 11 Phelps Way, Willington CT
510(k) summary
Statement
Third party review
No

Clearances, product code NBG

Trailing 12 months

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

FDA records show no clearances under product code NBG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NBG, 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