SOLOASSIST II
K-Number: K171947 · 2018-09-21
ApplicantAktormed GmbH
Decision Date2018-09-21
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SOLOASSIST II is a medical device manufactured by Aktormed GmbH. It received FDA 510(k) clearance on 2018-09-21 under approval number K171947. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SOLOASSIST II?
SOLOASSIST II is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Aktormed GmbH. The 510(k) number is K171947.
When was SOLOASSIST II approved by the FDA?
SOLOASSIST II received FDA 510(k) clearance on 2018-09-21, under approval number K171947.
What company makes SOLOASSIST II?
SOLOASSIST II is manufactured by Aktormed GmbH.
What is the FDA product code for SOLOASSIST II?
The FDA product code for SOLOASSIST II is NAY.
Other Devices by Aktormed GmbH
Related Devices (Code: NAY)
K162411da Vinci Xi 12 8 mm ReducerIntuitive Surgical, Inc.
K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.
K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.
K152892da Vinci Xi Surgical SystemIntuitive Surgical
K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.
K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.