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)

ACE SYSTEM

K-Number: K960853 · 1996-04-03

ApplicantXomed, Inc.
Decision Date1996-04-03
Product CodeEQJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1996-04-03 under 510(k) number K960853. The device is classified under product code EQJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE SYSTEM?

ACE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-03. The listed applicant is Xomed, Inc.. The 510(k) number is K960853.

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

ACE SYSTEM received FDA 510(k) clearance on 1996-04-03, under 510(k) number K960853.

Who is the listed applicant for ACE SYSTEM?

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

What is the FDA product code for ACE SYSTEM?

The FDA product code for ACE SYSTEM is EQJ.

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 Xomed, 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

View all 82 devices →

Related Devices (Code: EQJ)

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.

K161514Precision Thin Reciprocating Blade, 0.010in.Stryker CorporationK041985XPS CURVED BURMedtronic Xomed, Inc.K974232ESSENTIAL SHAVER SYSTEMGyrus Ent LLCK955704TREBAY MICRODEBRIDER SYSTEMTrebay Medical Corp.K955294SOF - ABRASION BURTrebay Medical Corp.K954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)Trebay Medical 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.

↑