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

Syringe, Irrigating (Non Dental)

21 CFR 880.6960 / General Hospital
FDA source (opens on fda.gov)

KYZ is the FDA product code for Syringe, Irrigating (Non Dental), a class I device type, regulated under 21 CFR 880.6960. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
KYZ
Device name
Syringe, Irrigating (Non Dental)
Regulation
21 CFR 880.6960
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
41
Ingested recalls
20

Clearances, product code KYZ

By decision year
41 clearances under product code KYZ with a decision year between 1978 and 2020, 1993 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KYZ by decision year
YearClearances
19781
19791
19801
19814
19821
19831
19884
19893
19904
19912
19935
19942
19952
19962
19971
19982
19991
20051
20091
20111
20201

Applicants with the most clearances

Product code KYZ
Applicants holding the most 510(k) clearances under product code KYZ
ApplicantClearances
Micromedics, Inc.4
Contour Fabricators of Florida, Inc.2
Instrument Makar, Inc.2
Nusurg, Inc.2
Summit Medical, LLC2
Sub-Q, Inc.2
Ackrad Laboratories1
Burron Medical Products, Inc.1
California Cardiac Systems, Inc.1
Custom Pack Reliability1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 341 companies shown, in name order