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)

SILICONE LARYNGEAL STENT

K-Number: K884810 · 1989-05-10

ApplicantHood Laboratories
Decision Date1989-05-10
Product CodeFWN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILICONE LARYNGEAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Hood Laboratories. It received FDA 510(k) clearance on 1989-05-10 under 510(k) number K884810. 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 SILICONE LARYNGEAL STENT?

SILICONE LARYNGEAL STENT is a medical device that received FDA 510(k) clearance on 1989-05-10. The listed applicant is Hood Laboratories. The 510(k) number is K884810.

When did SILICONE LARYNGEAL STENT receive FDA 510(k) clearance?

SILICONE LARYNGEAL STENT received FDA 510(k) clearance on 1989-05-10, under 510(k) number K884810.

Who is the listed applicant for SILICONE LARYNGEAL STENT?

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

What is the FDA product code for SILICONE LARYNGEAL STENT?

The FDA product code for SILICONE LARYNGEAL STENT 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 Hood Laboratories 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.

K921452ACOUSTIC RHINOMETERK920994HOOD NASAL SEPTAL BUTTONK905703KRUPIN EYE VALVE WITH DISKK904821ELIACHAR MODIFIED ESOPHAGEAL STENTK897049GIBSON ENDOLYMPHATIC SHUNTK897059HOOD SPEAKING VALVE

View all 19 devices →

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.K000154ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1E. Benson Hood Lab, Inc.K962693MONTGOMERY RADIOPAQUE LARYNGEAL KEELBoston Medical Products, Inc.K896667LORENZ STENTWalter Lorenz Surgical, Inc.K864936'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.

↑