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

Instrument, Biopsy, Suction

21 CFR 876.1075 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FCK is the FDA product code for Instrument, Biopsy, Suction, a class II device type, regulated under 21 CFR 876.1075. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FCK
Device name
Instrument, Biopsy, Suction
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
1

Clearances, product code FCK

By decision year
13 clearances under product code FCK with a decision year between 1990 and 2017, 1990 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FCK by decision year
YearClearances
19903
19912
19931
19941
19951
20051
20062
20111
20171

Applicants with the most clearances

Product code FCK
Applicants holding the most 510(k) clearances under product code FCK
ApplicantClearances
United States Endoscopy Group, Inc.4
Triton Technology, Inc.2
Wilson-Cook Medical Inc.2
Aus Systems Pty Ltd.1
Biopsys Medical, Inc.1
H & B Medical Technology, Inc.1
Medical Measurements, Inc.1
Mill-Rose Laboratory1

Companies listing this code with FDA

Companies whose registered establishments list this code