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

Tray, Biopsy, Without Biopsy Instruments

21 CFR 876.4730 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FCH is the FDA product code for Tray, Biopsy, Without Biopsy Instruments, a class I device type, regulated under 21 CFR 876.4730. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
FCH
Device name
Tray, Biopsy, Without Biopsy Instruments
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
14

Clearances, product code FCH

By decision year
2 clearances under product code FCH with a decision year between 1985 and 1988, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FCH by decision year
YearClearances
19851
19881

Applicants with the most clearances

Product code FCH
Applicants holding the most 510(k) clearances under product code FCH
ApplicantClearances
Kontron Instruments, Inc.1
Manan Manufacturing Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order