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)

TREACE MAGNUM OTO-TOOL SYSTEM

K-Number: K873154 · 1987-09-04

ApplicantTreace Medical, Inc.
Decision Date1987-09-04
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TREACE MAGNUM OTO-TOOL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K873154. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREACE MAGNUM OTO-TOOL SYSTEM?

TREACE MAGNUM OTO-TOOL SYSTEM is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Treace Medical, Inc.. The 510(k) number is K873154.

When did TREACE MAGNUM OTO-TOOL SYSTEM receive FDA 510(k) clearance?

TREACE MAGNUM OTO-TOOL SYSTEM received FDA 510(k) clearance on 1987-09-04, under 510(k) number K873154.

Who is the listed applicant for TREACE MAGNUM OTO-TOOL SYSTEM?

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

What is the FDA product code for TREACE MAGNUM OTO-TOOL SYSTEM?

The FDA product code for TREACE MAGNUM OTO-TOOL SYSTEM is ERL.

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 Treace 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERSK871706OPTHA PREP

View all 80 devices →

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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.

↑