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FDA 510(k)

Resolv Endoscopic Hemostat System

K-Number: K234131 · 2024-07-26

ApplicantHemostasis, LLC
Decision Date2024-07-26
Product CodeQAU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Resolv Endoscopic Hemostat System is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K234131. 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 Resolv Endoscopic Hemostat System?

Resolv Endoscopic Hemostat System is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Hemostasis, LLC. The 510(k) number is K234131.

When did Resolv Endoscopic Hemostat System receive FDA 510(k) clearance?

Resolv Endoscopic Hemostat System received FDA 510(k) clearance on 2024-07-26, under 510(k) number K234131.

Who is the listed applicant for Resolv Endoscopic Hemostat System?

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

What is the FDA product code for Resolv Endoscopic Hemostat System?

The FDA product code for Resolv Endoscopic Hemostat System is QAU.

Other records listing Hemostasis, LLC 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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintK210411PosiSep EAR Fragmentable Ear Dressing

Related Devices (Code: QAU)

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.

K261503PuraStat GI3-D Matrix, Inc.K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc.K253924PuraStat3-D Matrix Europe SASK240994NexpowderNextbiomedical Co., Ltd.K242250PuraStat3-D Matrix Europe SASK222481PuraStat3-D Matrix, Inc.

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.

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