510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834168Substantially Equivalent

Fibrinogen Uptake Sys -Various Models

Canberra Industries, Inc., Meriden CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834168 is the FDA 510(k) clearance record for FIBRINOGEN UPTAKE SYS -VARIOUS MODELS, a class I device, cleared for Canberra Industries, Inc. on under FDA product code JZD (Snare, Ear). FDA records list 3 510(k) clearances for Canberra Industries, Inc., from to . As of , FDA records show no recalls naming K834168.

Clearance record

Decision date
Received
(55 days to decision)
Product code
JZD Snare, Ear
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Canberra Industries, Inc. 45 Gracey Ave., Meriden CT
Third party review
No

Clearances, product code JZD

Trailing 12 months

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

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