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FDA 510(k)

U-Blade Veress Needle

K-Number: K162648 · 2016-12-12

ApplicantTianjin Uwell Medical Device Manufacturing Co., Ltd.
Decision Date2016-12-12
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

U-Blade Veress Needle is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162648. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-Blade Veress Needle?

U-Blade Veress Needle is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. The 510(k) number is K162648.

When did U-Blade Veress Needle receive FDA 510(k) clearance?

U-Blade Veress Needle received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162648.

Who is the listed applicant for U-Blade Veress Needle?

The FDA 510(k) record lists Tianjin Uwell Medical Device Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-Blade Veress Needle?

The FDA product code for U-Blade Veress Needle is HIF.

Other records listing Tianjin Uwell Medical Device Manufacturing 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.

K162387U-IGNITE Bladeless Trocar

Related Devices (Code: HIF)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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