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FDA 510(k)

ENFit to ENFit Extension Sets

K-Number: K230326 · 2023-11-02

ApplicantVesco Medical
Decision Date2023-11-02
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit to ENFit Extension Sets is the device name listed in this FDA 510(k) record. The listed applicant is Vesco Medical. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K230326. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENFit to ENFit Extension Sets?

ENFit to ENFit Extension Sets is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Vesco Medical. The 510(k) number is K230326.

When did ENFit to ENFit Extension Sets receive FDA 510(k) clearance?

ENFit to ENFit Extension Sets received FDA 510(k) clearance on 2023-11-02, under 510(k) number K230326.

Who is the listed applicant for ENFit to ENFit Extension Sets?

The FDA 510(k) record lists Vesco Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENFit to ENFit Extension Sets?

The FDA product code for ENFit to ENFit Extension Sets is PIF.

Other records listing Vesco Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: PIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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