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FDA 510(k)

RESOLUTION HEMOSTASIS CLIPPING DEVICE

K-Number: K040148 · 2004-04-22

ApplicantBoston Scientific Corp
Decision Date2004-04-22
Product CodeMCH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESOLUTION HEMOSTASIS CLIPPING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K040148. The device is classified under product code MCH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLUTION HEMOSTASIS CLIPPING DEVICE?

RESOLUTION HEMOSTASIS CLIPPING DEVICE is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is Boston Scientific Corp. The 510(k) number is K040148.

When did RESOLUTION HEMOSTASIS CLIPPING DEVICE receive FDA 510(k) clearance?

RESOLUTION HEMOSTASIS CLIPPING DEVICE received FDA 510(k) clearance on 2004-04-22, under 510(k) number K040148.

Who is the listed applicant for RESOLUTION HEMOSTASIS CLIPPING DEVICE?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESOLUTION HEMOSTASIS CLIPPING DEVICE?

The FDA product code for RESOLUTION HEMOSTASIS CLIPPING DEVICE is MCH.

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Related Devices (Code: MCH)

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.

K972745TITANIUM HEMOSTATIC CLIPEisner USA, Inc.K896998ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)S.P.K. Technology, 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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