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)

INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR

K-Number: K965001 · 1997-07-31

ApplicantIntuitive Surgical, Inc.
Decision Date1997-07-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR 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 1997-07-31 under 510(k) number K965001. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR?

INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K965001.

When did INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR receive FDA 510(k) clearance?

INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR received FDA 510(k) clearance on 1997-07-31, under 510(k) number K965001.

Who is the listed applicant for INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR?

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 INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR?

The FDA product code for INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR is GCJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K261823da Vinci Surgical System, Model IS5000K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

View all 164 devices →

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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.

↑