510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915801Substantially Equivalent

Bip-Coax-System

Uni-Quatro Industries Canada, Inc., Niagara Falls, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915801 is the FDA 510(k) clearance record for BIP-COAX-SYSTEM, a class II device, cleared for Uni-Quatro Industries Canada, Inc. on under FDA product code FCG (Biopsy Needle). FDA records list 3 510(k) clearances for Uni-Quatro Industries Canada, Inc., from to . As of , FDA records show one recall naming K915801.

Clearance record

Decision date
Received
(808 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Uni-Quatro Industries Canada, Inc. 6471 Kister Rd., Niagara Falls, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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