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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-12-13 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K193202.

When did EXALT Model D Single-Use Duodenoscope, EXALT Controller receive FDA 510(k) clearance?

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

Who is the listed applicant for EXALT Model D Single-Use Duodenoscope, EXALT Controller?

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 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.