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FDA 510(k)

Single-use Ureteral Access Sheath

K-Number: K240167 · 2024-10-08

Decision Date2024-10-08
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-use Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-10-08 under 510(k) number K240167. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-use Ureteral Access Sheath?

Single-use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2024-10-08. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K240167.

When did Single-use Ureteral Access Sheath receive FDA 510(k) clearance?

Single-use Ureteral Access Sheath received FDA 510(k) clearance on 2024-10-08, under 510(k) number K240167.

Who is the listed applicant for Single-use Ureteral Access Sheath?

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

What is the FDA product code for Single-use Ureteral Access Sheath?

The FDA product code for Single-use Ureteral Access Sheath is FED.

Related Clinical Trials

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.

Other records listing Hunan Vathin Medical Instrument 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.

View all 17 devices →

Related Devices (Code: FED)

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.