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FDA 510(k)

Habib EndoHPB

K-Number: K231533 · 2023-06-21

ApplicantBoston Scientific Corporation
Decision Date2023-06-21
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Habib EndoHPB is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-21 under approval number K231533. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Habib EndoHPB?

Habib EndoHPB is a medical device that received FDA 510(k) clearance on 2023-06-21. It is manufactured by Boston Scientific Corporation. The 510(k) number is K231533.

When was Habib EndoHPB approved by the FDA?

Habib EndoHPB received FDA 510(k) clearance on 2023-06-21, under approval number K231533.

What company makes Habib EndoHPB?

Habib EndoHPB is manufactured by Boston Scientific Corporation.

What is the FDA product code for Habib EndoHPB?

The FDA product code for Habib EndoHPB is KNS.

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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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