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FDA 510(k)

Picocare

K-Number: K162755 · 2017-06-12

Decision Date2017-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picocare is the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2017-06-12 under 510(k) number K162755. 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 Picocare?

Picocare is a medical device that received FDA 510(k) clearance on 2017-06-12. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K162755.

When did Picocare receive FDA 510(k) clearance?

Picocare received FDA 510(k) clearance on 2017-06-12, under 510(k) number K162755.

Who is the listed applicant for Picocare?

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

What is the FDA product code for Picocare?

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

Other records listing Wontech Co., 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.

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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.

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.