510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910769Substantially Equivalent

Surgitek(r) Ercp Contrast Media System

Surgitek Medical Engineering Corp., Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910769 is the FDA 510(k) clearance record for SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM, a class II device, cleared for Surgitek Medical Engineering Corp. on under FDA product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula). FDA's definition for product code ODD reads: "To identify stones, tumors, or narrowing in the biliary tree". FDA records list 11 510(k) clearances for Surgitek Medical Engineering Corp., from to . As of , FDA records show no recalls naming K910769.

Clearance record

Decision date
Received
(123 days to decision)
Product code
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgitek Medical Engineering Corp. 3037 Mt. Pleasant St., Racine WI
Third party review
No

Clearances, product code ODD

Trailing 12 months

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

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