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)

MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE

K-Number: K013861 · 2001-12-06

ApplicantElekta Instrument AB
Decision Date2001-12-06
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 2001-12-06 under 510(k) number K013861. 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 MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE?

MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Elekta Instrument AB. The 510(k) number is K013861.

When did MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE receive FDA 510(k) clearance?

MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE received FDA 510(k) clearance on 2001-12-06, under 510(k) number K013861.

Who is the listed applicant for MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE?

The FDA 510(k) record lists Elekta Instrument AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE?

The FDA product code for MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE 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 Elekta Instrument AB 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.

K190887Leksell Vantage Stereotactic SystemK173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconK173791Leksell GammaPlanK171123Leksell Vantage Stereotactic SystemK160440Leksell Gamma Knife IconK152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit

View all 31 devices →

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.

↑