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)

MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01

K-Number: K041897 · 2005-06-01

ApplicantSchaerer Mayfield USA, Inc.
Decision Date2005-06-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 is the device name listed in this FDA 510(k) record. The listed applicant is Schaerer Mayfield USA, Inc.. It received FDA 510(k) clearance on 2005-06-01 under 510(k) number K041897. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01?

MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is Schaerer Mayfield USA, Inc.. The 510(k) number is K041897.

When did MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 receive FDA 510(k) clearance?

MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 received FDA 510(k) clearance on 2005-06-01, under 510(k) number K041897.

Who is the listed applicant for MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01?

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

What is the FDA product code for MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01?

The FDA product code for MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 is HAW.

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 Schaerer Mayfield USA, 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.

K053210MAYFIELD SCANMATE MOBILE CT SYSTEM

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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.

↑