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)

AVCORE SYSTEM

K-Number: K990816 · 1999-09-24

ApplicantModular Cutting Systems, Inc.
Decision Date1999-09-24
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AVCORE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Modular Cutting Systems, Inc.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K990816. 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 AVCORE SYSTEM?

AVCORE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Modular Cutting Systems, Inc.. The 510(k) number is K990816.

When did AVCORE SYSTEM receive FDA 510(k) clearance?

AVCORE SYSTEM received FDA 510(k) clearance on 1999-09-24, under 510(k) number K990816.

Who is the listed applicant for AVCORE SYSTEM?

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

What is the FDA product code for AVCORE SYSTEM?

The FDA product code for AVCORE SYSTEM 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 Modular Cutting Systems, 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.

K991037EUCLID REDUCTION AND GUIDANCE SYSTEM

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.

↑