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)

ACUFEX DREZ COMMUNICATING DRILL GUIDE

K-Number: K834350 · 1984-03-19

ApplicantAcufex Microsurgical, Inc.
Decision Date1984-03-19
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUFEX DREZ COMMUNICATING DRILL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K834350. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX DREZ COMMUNICATING DRILL GUIDE?

ACUFEX DREZ COMMUNICATING DRILL GUIDE is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K834350.

When did ACUFEX DREZ COMMUNICATING DRILL GUIDE receive FDA 510(k) clearance?

ACUFEX DREZ COMMUNICATING DRILL GUIDE received FDA 510(k) clearance on 1984-03-19, under 510(k) number K834350.

Who is the listed applicant for ACUFEX DREZ COMMUNICATING DRILL GUIDE?

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

What is the FDA product code for ACUFEX DREZ COMMUNICATING DRILL GUIDE?

The FDA product code for ACUFEX DREZ COMMUNICATING DRILL GUIDE is FZX.

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 Acufex Microsurgical, 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

View all 78 devices →

Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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.

↑