FDA 510(k)

EXALT Model D Single-Use Duodenoscope, EXALT Controller

K-Number: K193202 · 2019-12-13

Decision Date2019-12-13

Product CodeFDT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EXALT Model D Single-Use Duodenoscope, EXALT Controller is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-12-13 under approval number K193202. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXALT Model D Single-Use Duodenoscope, EXALT Controller?

EXALT Model D Single-Use Duodenoscope, EXALT Controller is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Boston Scientific Corporation. The 510(k) number is K193202.

When was EXALT Model D Single-Use Duodenoscope, EXALT Controller approved by the FDA?

EXALT Model D Single-Use Duodenoscope, EXALT Controller received FDA 510(k) clearance on 2019-12-13, under approval number K193202.

What company makes EXALT Model D Single-Use Duodenoscope, EXALT Controller?

EXALT Model D Single-Use Duodenoscope, EXALT Controller is manufactured by Boston Scientific Corporation.

What is the FDA product code for EXALT Model D Single-Use Duodenoscope, EXALT Controller?

The FDA product code for EXALT Model D Single-Use Duodenoscope, EXALT Controller is FDT.

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Related Devices (Code: FDT)

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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.