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FDA 510(k)

Speedboat Flush SB1 Instrument

K-Number: K230328 · 2023-10-31

ApplicantCreo Medical, Ltd.
Decision Date2023-10-31
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Speedboat Flush SB1 Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K230328. 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 Speedboat Flush SB1 Instrument?

Speedboat Flush SB1 Instrument is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K230328.

When did Speedboat Flush SB1 Instrument receive FDA 510(k) clearance?

Speedboat Flush SB1 Instrument received FDA 510(k) clearance on 2023-10-31, under 510(k) number K230328.

Who is the listed applicant for Speedboat Flush SB1 Instrument?

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

What is the FDA product code for Speedboat Flush SB1 Instrument?

The FDA product code for Speedboat Flush SB1 Instrument is KNS.

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Related Devices (Code: KNS)

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.

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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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