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)

LARYNGEAL AUGMENTATION IMPLANT

K-Number: K033398 · 2003-12-12

ApplicantBioform, Inc.
Decision Date2003-12-12
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LARYNGEAL AUGMENTATION IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Bioform, Inc.. It received FDA 510(k) clearance on 2003-12-12 under 510(k) number K033398. The device is classified under product code MIX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARYNGEAL AUGMENTATION IMPLANT?

LARYNGEAL AUGMENTATION IMPLANT is a medical device that received FDA 510(k) clearance on 2003-12-12. The listed applicant is Bioform, Inc.. The 510(k) number is K033398.

When did LARYNGEAL AUGMENTATION IMPLANT receive FDA 510(k) clearance?

LARYNGEAL AUGMENTATION IMPLANT received FDA 510(k) clearance on 2003-12-12, under 510(k) number K033398.

Who is the listed applicant for LARYNGEAL AUGMENTATION IMPLANT?

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

What is the FDA product code for LARYNGEAL AUGMENTATION IMPLANT?

The FDA product code for LARYNGEAL AUGMENTATION IMPLANT is MIX.

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 Bioform, 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.

K030682CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3K013243COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1K012955COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER

Related Devices (Code: MIX)

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.

K240919Silk Voice (SMI-04)Sofregen MedicalK180631Silk VoiceSofregen Medical, Inc.K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTCytophil, Inc.K083783VF LIQUIGELCoapt Systems, Inc.K081815VOCALIS GELCytophil, Inc.K081816VOCALIS AND VOCALIS SMCytophil, 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.

↑