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)

IRISeg

K-Number: K251763 · 2025-12-16

ApplicantIntuitive Surgical, Inc.
Decision Date2025-12-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IRISeg is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K251763. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRISeg?

IRISeg is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K251763.

When did IRISeg receive FDA 510(k) clearance?

IRISeg received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251763.

Who is the listed applicant for IRISeg?

The FDA 510(k) record lists Intuitive Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRISeg?

The FDA product code for IRISeg is QIH.

Related Clinical Trials

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.

NCT04403022da Vinci SP® Investigational Device Exemption Study in Colorectal ProceduresACTIVE_NOT_RECRUITINGNCT05867927GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological IndicationsRECRUITINGNCT06084208Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCTCOMPLETEDNCT06308120A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENBACTIVE_NOT_RECRUITINGNCT06923774European Real-World Registry for Use of the Ion Endoluminal SystemRECRUITINGNCT07655505Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve RepairRECRUITING

Other records listing Intuitive Surgical, Inc. 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.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging SystemK253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

View all 124 devices →

Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, 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.

↑