Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cypris eXact Suturing System

K-Number: K233355 · 2024-01-12

ApplicantCypris Medical
Decision Date2024-01-12
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cypris eXact Suturing System is the device name listed in this FDA 510(k) record. The listed applicant is Cypris Medical. It received FDA 510(k) clearance on 2024-01-12 under 510(k) 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. The listed applicant is Cypris Medical. The 510(k) number is K233355.

When did Cypris eXact Suturing System receive FDA 510(k) clearance?

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

Who is the listed applicant for Cypris eXact Suturing System?

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 Suturing System?

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

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.

K240185Cypris eXact Suture Placement Device

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLCK193530Deklene MAXXTeleflex Medical

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.

↑