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)

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

K-Number: K000154 · 2000-03-29

ApplicantE. Benson Hood Lab, Inc.
Decision Date2000-03-29
Product CodeFWN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 is the device name listed in this FDA 510(k) record. The listed applicant is E. Benson Hood Lab, Inc.. It received FDA 510(k) clearance on 2000-03-29 under 510(k) number K000154. The device is classified under product code FWN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1?

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 is a medical device that received FDA 510(k) clearance on 2000-03-29. The listed applicant is E. Benson Hood Lab, Inc.. The 510(k) number is K000154.

When did ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 receive FDA 510(k) clearance?

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 received FDA 510(k) clearance on 2000-03-29, under 510(k) number K000154.

Who is the listed applicant for ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1?

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

What is the FDA product code for ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1?

The FDA product code for ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 is FWN.

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 E. Benson Hood Lab, 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.

K011329ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETERK974132VOICE MASTER PROSTHESIS

Related Devices (Code: FWN)

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.

K091135RUTTER SUPRA STOMAL STENTSBoston Medical Products, Inc.K962693MONTGOMERY RADIOPAQUE LARYNGEAL KEELBoston Medical Products, Inc.K896667LORENZ STENTWalter Lorenz Surgical, Inc.K884810SILICONE LARYNGEAL STENTHood LaboratoriesK864936'EXMOOR' DAS GUPTA LARYNGEAL KEELExmoor Plastics , Ltd.K853726LARYNGEALHood Laboratories

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.

↑