FDA 510(k)

Cypris eXact Suturing System

K-Number: K233355 · 2024-01-12

Decision Date2024-01-12

Product CodeGAW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cypris eXact Suturing System is a medical device manufactured by Cypris Medical. It received FDA 510(k) clearance on 2024-01-12 under approval number K233355. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cypris eXact Suturing System?

Cypris eXact Suturing System is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by Cypris Medical. The 510(k) number is K233355.

When was Cypris eXact Suturing System approved by the FDA?

Cypris eXact Suturing System received FDA 510(k) clearance on 2024-01-12, under approval number K233355.

What company makes Cypris eXact Suturing System?

Cypris eXact Suturing System is manufactured by Cypris Medical.

What is the FDA product code for Cypris eXact Suturing System?

The FDA product code for Cypris eXact Suturing System is GAW.

Related Clinical Trials

NCT04829994 Post-Market Clinical Follow-Up onTVT EXACT® Continence System ACTIVE_NOT_RECRUITING NCT07526818 Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator. ACTIVE_NOT_RECRUITING

Other Devices by Cypris Medical

K240185Cypris eXact Suture Placement Device

Related Devices (Code: GAW)

K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A. K171005Silhouette FeatherliftSilhouette Lift, Inc. K162617NobleStitch ELNobles Medical Technologies Ii, Inc. K173747REXLENESm Eng Co., Ltd. K180321Aesculap Optilene Nonabsorbable SutureAesculap, Inc.

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.