FDA 510(k)

Nexpowder

K-Number: K202929 · 2022-09-16

Decision Date2022-09-16

Product CodeQAU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Nexpowder is the device name listed in this FDA 510(k) record. The listed applicant is Nextbiomedical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K202929. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nexpowder?

Nexpowder is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Nextbiomedical Co., Ltd.. The 510(k) number is K202929.

When did Nexpowder receive FDA 510(k) clearance?

Nexpowder received FDA 510(k) clearance on 2022-09-16, under 510(k) number K202929.

Who is the listed applicant for Nexpowder?

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

What is the FDA product code for Nexpowder?

The FDA product code for Nexpowder is QAU.

Other records listing Nextbiomedical 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.

K240994Nexpowder

Related Devices (Code: QAU)

K261503PuraStat GI3-D Matrix, Inc.K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc.K253924PuraStat3-D Matrix Europe SAS K240994NexpowderNextbiomedical Co., Ltd.K242250PuraStat3-D Matrix Europe SAS K234131Resolv Endoscopic Hemostat SystemHemostasis, LLC

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.