510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921091Substantially Equivalent

Cholangiolapcath(tm)

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921091 is the FDA 510(k) clearance record for CHOLANGIOLAPCATH(TM), a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code GBZ (Catheter, Cholangiography). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K921091.

Clearance record

Decision date
Received
(61 days to decision)
Product code
GBZ Catheter, Cholangiography
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GBZ

Trailing 12 months

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

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