Pastelle
K-Number: K250165 · 2025-07-03
ApplicantWontech Co., Ltd.
Decision Date2025-07-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Pastelle is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under approval number K250165. 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?
Pastelle is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K250165.
When was Pastelle approved by the FDA?
Pastelle received FDA 510(k) clearance on 2025-07-03, under approval number K250165.
What company makes Pastelle?
Pastelle is manufactured by Wontech Co., Ltd..
What is the FDA product code for Pastelle?
The FDA product code for Pastelle is GEX. This falls under the Gastroenterology category.
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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.