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)

FENESTRA HOOK

K-Number: K841359 · 1984-07-18

ApplicantTreace Medical, Inc.
Decision Date1984-07-18
Product CodeIYL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FENESTRA HOOK 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 1984-07-18 under 510(k) number K841359. The device is classified under product code IYL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FENESTRA HOOK?

FENESTRA HOOK is a medical device that received FDA 510(k) clearance on 1984-07-18. The listed applicant is Treace Medical, Inc.. The 510(k) number is K841359.

When did FENESTRA HOOK receive FDA 510(k) clearance?

FENESTRA HOOK received FDA 510(k) clearance on 1984-07-18, under 510(k) number K841359.

Who is the listed applicant for FENESTRA HOOK?

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 FENESTRA HOOK?

The FDA product code for FENESTRA HOOK is IYL.

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 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

View all 80 devices →

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.

↑