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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Aktormed GmbH. It received FDA 510(k) clearance on 2018-09-21 under 510(k) 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. The listed applicant is Aktormed GmbH. The 510(k) number is K171947.

When did SOLOASSIST II receive FDA 510(k) clearance?

SOLOASSIST II received FDA 510(k) clearance on 2018-09-21, under 510(k) number K171947.

Who is the listed applicant for SOLOASSIST II?

The FDA 510(k) record lists Aktormed GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLOASSIST II?

The FDA product code for SOLOASSIST II is NAY.

Other records listing Aktormed GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261573ENDOSCOPE HOLDER (182214)K233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894K232405ENDOFIX EXOK200473SoloAsisst II, Voice Control

Related Devices (Code: NAY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K260695da Vinci Firefly Imaging SystemIntuitive SurgicalK254192Senhance Ultrasonic SystemAsensus SurgicalK253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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