Pastelle
K-Number: K250165 · 2025-07-03
Device Summary
Frequently Asked Questions
What is the Pastelle?
Pastelle is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K250165.
When did Pastelle receive FDA 510(k) clearance?
Pastelle received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250165.
Who is the listed applicant for Pastelle?
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?
The FDA product code for Pastelle 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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.