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

FDA 510(k)

Cypris eXact Suture Placement Device

K-Number: K240185 · 2024-05-03

ApplicantCypris Medical
Decision Date2024-05-03
Product CodeGEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cypris eXact Suture Placement Device is a medical device manufactured by Cypris Medical. It received FDA 510(k) clearance on 2024-05-03 under approval 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. It is manufactured by Cypris Medical. The 510(k) number is K240185.

When was Cypris eXact Suture Placement Device approved by the FDA?

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

What company makes Cypris eXact Suture Placement Device?

Cypris eXact Suture Placement Device is manufactured by Cypris Medical.

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

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

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07600502 Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics. NOT_YET_RECRUITING NCT03086096 CIRSE Registry for LifePearl Microspheres COMPLETED NCT07299006 Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children. RECRUITING

Other Devices by Cypris Medical

K233355Cypris eXact Suturing System

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.

↑