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)

VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT

K-Number: K974311 · 1998-03-04

ApplicantGyrus Ent LLC
Decision Date1998-03-04
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 1998-03-04 under 510(k) number K974311. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT?

VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT is a medical device that received FDA 510(k) clearance on 1998-03-04. The listed applicant is Gyrus Ent LLC. The 510(k) number is K974311.

When did VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT receive FDA 510(k) clearance?

VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT received FDA 510(k) clearance on 1998-03-04, under 510(k) number K974311.

Who is the listed applicant for VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT?

The FDA 510(k) record lists Gyrus Ent LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT?

The FDA product code for VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT is KHJ.

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 Gyrus Ent LLC 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.

K040996RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEMK034004DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLEK033089HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEMK033554SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISK030343DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACEK021595GYRUS ENT NERVE STIMULATOR

View all 28 devices →

Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.

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.

↑