FDA 510(k)

Cypris eXact Suture Placement Device

K-Number: K240185 · 2024-05-03

Decision Date2024-05-03

Product CodeGEJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cypris eXact Suture Placement Device is the device name listed in this FDA 510(k) record. The listed applicant is Cypris Medical. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K240185. The device is classified under product code GEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cypris eXact Suture Placement Device?

Cypris eXact Suture Placement Device is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Cypris Medical. The 510(k) number is K240185.

When did Cypris eXact Suture Placement Device receive FDA 510(k) clearance?

Cypris eXact Suture Placement Device received FDA 510(k) clearance on 2024-05-03, under 510(k) number K240185.

Who is the listed applicant for Cypris eXact Suture Placement Device?

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

What is the FDA product code for Cypris eXact Suture Placement Device?

The FDA product code for Cypris eXact Suture Placement Device is GEJ.

Other records listing Cypris 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.

K233355Cypris eXact Suturing System

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.