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

Electrode, Ph, Stomach

21 CFR 876.1400 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FFT is the FDA product code for Electrode, Ph, Stomach, a class I device type, regulated under 21 CFR 876.1400. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
FFT
Device name
Electrode, Ph, Stomach
Regulation
21 CFR 876.1400
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
49
Ingested recalls
11

Clearances, product code FFT

By decision year
49 clearances under product code FFT with a decision year between 1981 and 2010, 1985 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code FFT by decision year
YearClearances
19811
19822
19843
19856
19864
19876
19885
19892
19903
19913
19923
19942
19953
19962
19971
20001
20021
20101

Applicants with the most clearances

Product code FFT
Applicants holding the most 510(k) clearances under product code FFT
ApplicantClearances
Synectics-Dantec10
Diamond Medical, Inc.4
Diversatek Healthcare Inc4
Tonometrics, Inc.3
Biosearch Medical Products, Inc.2
Chemfet Corp.2
Oakfield Instruments, Ltd.2
Sensatronix Medical Systems, Inc.2
Akron City Hospital1
American Endoscopy, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code