FDA 510(k)

Habib EndoHPB

K-Number: K231533 · 2023-06-21

Decision Date2023-06-21

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Habib EndoHPB is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-21 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K231533.

When did Habib EndoHPB receive FDA 510(k) clearance?

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

Who is the listed applicant for Habib EndoHPB?

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

What is the FDA product code for Habib EndoHPB?

The FDA product code for Habib EndoHPB is KNS.

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Related Devices (Code: 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.