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

Cystourethroscope

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

FBO is the FDA product code for Cystourethroscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FBO
Device name
Cystourethroscope
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
19
Ingested recalls
7

Clearances, product code FBO

By decision year
19 clearances under product code FBO with a decision year between 1985 and 2025, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FBO by decision year
YearClearances
19851
19871
19911
19943
19953
19961
19971
20011
20061
20071
20082
20141
20241
20251

Applicants with the most clearances

Product code FBO
Applicants holding the most 510(k) clearances under product code FBO
ApplicantClearances
Karl Storz Endoscopy-America, Inc.5
Karl Storz SE & Co. KG2
Richard Wolf Medical Instruments Corp.2
Cabot Medical Corp.1
Epitek, Inc.1
Galileo Electro-Optics Corp.1
Laserscope1
OLYMPUS Corporation of the Americas1
Olympus Corp.1
Smith & Nephew, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order