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)

MEDNEXT SURGICAL BUR

K-Number: K970023 · 1997-02-28

ApplicantMednext, Inc.
Decision Date1997-02-28
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDNEXT SURGICAL BUR is the device name listed in this FDA 510(k) record. The listed applicant is Mednext, Inc.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K970023. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDNEXT SURGICAL BUR?

MEDNEXT SURGICAL BUR is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Mednext, Inc.. The 510(k) number is K970023.

When did MEDNEXT SURGICAL BUR receive FDA 510(k) clearance?

MEDNEXT SURGICAL BUR received FDA 510(k) clearance on 1997-02-28, under 510(k) number K970023.

Who is the listed applicant for MEDNEXT SURGICAL BUR?

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

What is the FDA product code for MEDNEXT SURGICAL BUR?

The FDA product code for MEDNEXT SURGICAL BUR is HWE.

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 Mednext, 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.

K983092TRITON HUDSON CHUCK ATTACHMENTK972308MEDNEXT 1000 DRILLK943108MEDNEXT MICRO-DRILLK935861MEDNEXT BURK935584MEDNEXT BURK926547MEDNEXT 1000 BONE DISSECTING SYSTEM

View all 7 devices →

Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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.

↑