510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FERClass II

Anoscope And Accessories

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

FER is the FDA product code for Anoscope And Accessories, 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 anus and rectum". As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FER
Device name
Anoscope And Accessories
FDA definition
To examine and perform procedures within the anus and rectum.
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
27
Ingested recalls
1

Clearances, product code FER

By decision year
27 clearances under product code FER with a decision year between 1977 and 2025, 2000 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FER by decision year
YearClearances
19771
19811
19831
19861
19881
19931
20002
20011
20021
20061
20071
20081
20092
20101
20112
20122
20131
20141
20171
20211
20231
20241
20251

Applicants with the most clearances

Product code FER
Applicants holding the most 510(k) clearances under product code FER
ApplicantClearances
Applied Medical Resources Corp4
Thd SpA3
Sightline Technologies, Ltd.2
Welch Allyn Inc2
Angiologica B. M. SRL1
Baxter Healthcare Corporation1
Canadian Theatre Products, Ltd.1
Cook Ireland Ltd.1
Dispos-A-Scope1
Ethicon Endo-Surgery Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order