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FDA 510(k)

Pastelle Pro

K-Number: K241527 · 2025-02-14

ApplicantWontech Co., Ltd.
Decision Date2025-02-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pastelle Pro 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 2025-02-14 under 510(k) number K241527. 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 Pastelle Pro?

Pastelle Pro is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K241527.

When did Pastelle Pro receive FDA 510(k) clearance?

Pastelle Pro received FDA 510(k) clearance on 2025-02-14, under 510(k) number K241527.

Who is the listed applicant for Pastelle Pro?

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 Pastelle Pro?

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

Other records listing Wontech Co., Ltd. as applicant

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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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