SANDRO Dual
K-Number: K252877 · 2025-12-19
Device Summary
Frequently Asked Questions
What is the SANDRO Dual?
SANDRO Dual is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K252877.
When did SANDRO Dual receive FDA 510(k) clearance?
SANDRO Dual received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252877.
Who is the listed applicant for SANDRO Dual?
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 SANDRO Dual?
The FDA product code for SANDRO Dual 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.