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

Software Controlled Endoscope And Instrument Holder

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

QZB is the FDA product code for Software Controlled Endoscope And Instrument Holder, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To hold and position endoscopes and instruments". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QZB
Device name
Software Controlled Endoscope And Instrument Holder
FDA definition
To hold and position endoscopes and instruments.
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
4
Ingested recalls
0

Clearances, product code QZB

By decision year
4 clearances under product code QZB with a decision year between 2024 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QZB by decision year
YearClearances
20241
20252
20261

Applicants with the most clearances

Product code QZB
Applicants holding the most 510(k) clearances under product code QZB
ApplicantClearances
AKTORmed GmbH2
Moon Surgical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code