510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233312Substantially Equivalent

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894

AKTORmed GmbH, Neutraubling, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233312 is the FDA 510(k) clearance record for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894, a class II device, cleared for Aktormed GmbH on under FDA product code QZB (Software Controlled Endoscope And Instrument Holder). FDA's definition for product code QZB reads: "To hold and position endoscopes and instruments". FDA records list 5 510(k) clearances for Aktormed GmbH, from to . As of , FDA records show no recalls naming K233312.

Clearance record

Decision date
Received
(314 days to decision)
Product code
QZB Software Controlled Endoscope And Instrument Holder
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Aktormed GmbH Neugablonzer Strasse 13, Neutraubling, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QZB

Trailing 12 months
1 clearance under product code QZB in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QZB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260