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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 a medical device manufactured by Creo Medical, Ltd.. It received FDA 510(k) clearance on 2023-10-31 under approval 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. It is manufactured by Creo Medical, Ltd.. The 510(k) number is K230328.

When was Speedboat Flush SB1 Instrument approved by the FDA?

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

What company makes Speedboat Flush SB1 Instrument?

Speedboat Flush SB1 Instrument is manufactured by Creo Medical, Ltd..

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

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

Other Devices by Creo Medical, Ltd.

K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory K200003NP1 Instrument, Creo Electrosurgical System K192905Creo Electrosurgical System with HS1 Hemostasis Accessory K200298ABI Instrument, Creo Electrosurgical System K223138AB1 Electrosurgical Instrument, Creo Electrosurgical System K221672Creo Electrosurgical System with NP1 Instrument

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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.

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