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

Resectoscope

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

FJL is the FDA product code for Resectoscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 33 recalls.

Classification record

Product code
FJL
Device name
Resectoscope
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
33

Clearances, product code FJL

By decision year
24 clearances under product code FJL with a decision year between 1976 and 2024, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FJL by decision year
YearClearances
19761
19911
19921
19931
19943
19952
19962
19972
20001
20041
20051
20071
20101
20171
20192
20232
20241

Applicants with the most clearances

Product code FJL
Applicants holding the most 510(k) clearances under product code FJL
ApplicantClearances
Karl Storz Endoscopy-America, Inc.5
Corinth Medtech, Inc.4
Olympus Corp.3
Richard Wolf Medical Instruments Corp.3
Gynecare Innovation Center2
Comeg Endoscopy1
Gyrus ACMI, Inc.1
J-Tech, Inc.1
Karl Storz SE & Co. KG1
National Advanced Endoscopy Devices, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order