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)

REPROCESSED LINVATEC ARTHROSCOPIC BURS

K-Number: K012630 · 2001-11-09

ApplicantAlliance Medical, Inc.
Decision Date2001-11-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REPROCESSED LINVATEC ARTHROSCOPIC BURS is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Medical, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012630. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED LINVATEC ARTHROSCOPIC BURS?

REPROCESSED LINVATEC ARTHROSCOPIC BURS is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Alliance Medical, Inc.. The 510(k) number is K012630.

When did REPROCESSED LINVATEC ARTHROSCOPIC BURS receive FDA 510(k) clearance?

REPROCESSED LINVATEC ARTHROSCOPIC BURS received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012630.

Who is the listed applicant for REPROCESSED LINVATEC ARTHROSCOPIC BURS?

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

What is the FDA product code for REPROCESSED LINVATEC ARTHROSCOPIC BURS?

The FDA product code for REPROCESSED LINVATEC ARTHROSCOPIC BURS is HRX.

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 Alliance Medical, 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.

K051438VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)K050518REPROCESSED PHACOEMUISIFICATION TIPSK030187REPROCESSED ELECTROPHYSIOLOGY CATHETERK021654REPROCESSED COMPRESSION SLEEVEK012634REPROCESSED EXTERNAL FIXATION DEVICEK012613REPROCSSED LINVATEC SHAVERS

View all 11 devices →

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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.

↑