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FDA 510(k)

ASSISTO Universal Applicator Clamping Device

K-Number: K201279 · 2020-07-10

ApplicantGeomed Medizin-Technik GmbH & Co. KG
Decision Date2020-07-10
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASSISTO Universal Applicator Clamping Device is a medical device manufactured by Geomed Medizin-Technik GmbH & Co. KG. It received FDA 510(k) clearance on 2020-07-10 under approval number K201279. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSISTO Universal Applicator Clamping Device?

ASSISTO Universal Applicator Clamping Device is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Geomed Medizin-Technik GmbH & Co. KG. The 510(k) number is K201279.

When was ASSISTO Universal Applicator Clamping Device approved by the FDA?

ASSISTO Universal Applicator Clamping Device received FDA 510(k) clearance on 2020-07-10, under approval number K201279.

What company makes ASSISTO Universal Applicator Clamping Device?

ASSISTO Universal Applicator Clamping Device is manufactured by Geomed Medizin-Technik GmbH & Co. KG.

What is the FDA product code for ASSISTO Universal Applicator Clamping Device?

The FDA product code for ASSISTO Universal Applicator Clamping Device is JAQ.

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Related PubMed Literature

PMID: 41967338 Patient-tailored brachytherapy applicator development in compliance with the EU medical device regulation. Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) (2026)

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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.

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