510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802956Substantially Equivalent

Gambro a-V Fistula Needle Set

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

K802956 is the FDA 510(k) clearance record for GAMBRO A-V FISTULA NEEDLE SET, a class II device, cleared for Gambro, Inc. on under FDA product code FIE (Needle, Fistula). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K802956.

Clearance record

Decision date
Received
(32 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FIE

Trailing 12 months
1 clearance under product code FIE in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FIE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260