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FDA 510(k)

HandPICO

K-Number: K220041 · 2022-05-05

ApplicantVydence Medical Industria E Comercio Ltda
Decision Date2022-05-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HandPICO is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K220041. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HandPICO?

HandPICO is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Vydence Medical Industria E Comercio Ltda. The 510(k) number is K220041.

When did HandPICO receive FDA 510(k) clearance?

HandPICO received FDA 510(k) clearance on 2022-05-05, under 510(k) number K220041.

Who is the listed applicant for HandPICO?

The FDA 510(k) record lists Vydence Medical Industria E Comercio Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HandPICO?

The FDA product code for HandPICO is GEX. This falls under the Gastroenterology category.

Other records listing Vydence Medical Industria E Comercio Ltda 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.

K202998Vydence Zye and Vydence OneK190007Vydence Laser FamilyK171443Etherea MX

Related Devices (Code: GEX)

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.

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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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