510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830840Substantially Equivalent

Open Ended Ureteral Catheter

Van-Tec, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830840 is the FDA 510(k) clearance record for OPEN ENDED URETERAL CATHETER, a class II device, cleared for Van-Tec, Inc. on under FDA product code GBM (Catheter, Urethral). FDA records list 52 510(k) clearances for Van-Tec, Inc., from to . As of , FDA records show 4 recalls naming K830840.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GBM Catheter, Urethral
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Van-Tec, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GBM

Trailing 12 months

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

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