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

Sigmoidoscope And Accessories, Flexible/Rigid

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FAM is the FDA product code for Sigmoidoscope And Accessories, Flexible/Rigid, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "to examine and perform procedures within the sigmoid (descending) colon". As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FAM
Device name
Sigmoidoscope And Accessories, Flexible/Rigid
FDA definition
to examine and perform procedures within the sigmoid (descending) colon
Regulation
21 CFR 876.1500
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
No
Ingested clearances
24
Ingested recalls
2

Clearances, product code FAM

By decision year
24 clearances under product code FAM with a decision year between 1976 and 1997, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FAM by decision year
YearClearances
19761
19773
19793
19811
19822
19891
19921
19941
19954
19964
19973

Applicants with the most clearances

Product code FAM
Applicants holding the most 510(k) clearances under product code FAM
ApplicantClearances
Pentax Precision Instrument Corp.6
Cogentix Medical, Inc.5
Welch Allyn Inc4
American Optical Corp.2
Akos Biomedical, Inc.1
Dynatech Cryomedical Co.1
Harvard Laboratories1
Icl Scientific1
Schott Fiber Optics, Inc.1
Smithkline Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order