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FDA 510(k)

NerivioInfinity

K-Number: K232152 · 2023-11-08

Decision Date2023-11-08
Product CodeQGT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NerivioInfinity is the device name listed in this FDA 510(k) record. The listed applicant is Theranica Bioelectronics , Ltd.. It received FDA 510(k) clearance on 2023-11-08 under 510(k) number K232152. The device is classified under product code QGT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NerivioInfinity?

NerivioInfinity is a medical device that received FDA 510(k) clearance on 2023-11-08. The listed applicant is Theranica Bioelectronics , Ltd.. The 510(k) number is K232152.

When did NerivioInfinity receive FDA 510(k) clearance?

NerivioInfinity received FDA 510(k) clearance on 2023-11-08, under 510(k) number K232152.

Who is the listed applicant for NerivioInfinity?

The FDA 510(k) record lists Theranica Bioelectronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NerivioInfinity?

The FDA product code for NerivioInfinity is QGT.

Other records listing Theranica Bioelectronics , Ltd. 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.

Related Devices (Code: QGT)

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.

Official Source

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