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FDA 510(k)

AutoCap RX

K-Number: K210353 · 2021-05-06

ApplicantBoston Scientific Corporation
Decision Date2021-05-06
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AutoCap RX is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-05-06 under approval number K210353. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AutoCap RX?

AutoCap RX is a medical device that received FDA 510(k) clearance on 2021-05-06. It is manufactured by Boston Scientific Corporation. The 510(k) number is K210353.

When was AutoCap RX approved by the FDA?

AutoCap RX received FDA 510(k) clearance on 2021-05-06, under approval number K210353.

What company makes AutoCap RX?

AutoCap RX is manufactured by Boston Scientific Corporation.

What is the FDA product code for AutoCap RX?

The FDA product code for AutoCap RX is ODC.

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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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