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FDA 510(k)

VERSAJET Hydrosurgery System (III)

K-Number: K220964 · 2023-05-16

ApplicantSmith & Nephew Medical Limited
Decision Date2023-05-16
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERSAJET Hydrosurgery System (III) is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2023-05-16 under approval number K220964. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSAJET Hydrosurgery System (III)?

VERSAJET Hydrosurgery System (III) is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K220964.

When was VERSAJET Hydrosurgery System (III) approved by the FDA?

VERSAJET Hydrosurgery System (III) received FDA 510(k) clearance on 2023-05-16, under approval number K220964.

What company makes VERSAJET Hydrosurgery System (III)?

VERSAJET Hydrosurgery System (III) is manufactured by Smith & Nephew Medical Limited.

What is the FDA product code for VERSAJET Hydrosurgery System (III)?

The FDA product code for VERSAJET Hydrosurgery System (III) is FQH.

Related Clinical Trials

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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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