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)

EFTEKHAR RECHANNELIZATION DRILL GUIDE

K-Number: K864314 · 1986-11-19

ApplicantThe Anspach Effort, Inc.
Decision Date1986-11-19
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EFTEKHAR RECHANNELIZATION DRILL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 1986-11-19 under 510(k) number K864314. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EFTEKHAR RECHANNELIZATION DRILL GUIDE?

EFTEKHAR RECHANNELIZATION DRILL GUIDE is a medical device that received FDA 510(k) clearance on 1986-11-19. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K864314.

When did EFTEKHAR RECHANNELIZATION DRILL GUIDE receive FDA 510(k) clearance?

EFTEKHAR RECHANNELIZATION DRILL GUIDE received FDA 510(k) clearance on 1986-11-19, under 510(k) number K864314.

Who is the listed applicant for EFTEKHAR RECHANNELIZATION DRILL GUIDE?

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

What is the FDA product code for EFTEKHAR RECHANNELIZATION DRILL GUIDE?

The FDA product code for EFTEKHAR RECHANNELIZATION DRILL GUIDE is HSZ.

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 The Anspach Effort, 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.

K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)K183545Anspach Helix Dissection ToolsK180063OCM-G1 AttachmentK131053ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMK113476ANSPACH DISSECTION TOOLSK082637CRANIAL PERFORATOR

View all 59 devices →

Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, 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.

↑