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)

NASOPORE EAR, MODELS ND04, ND05

K-Number: K062540 · 2006-10-18

ApplicantPolyganics B.V.,
Decision Date2006-10-18
Product CodeKCN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NASOPORE EAR, MODELS ND04, ND05 is the device name listed in this FDA 510(k) record. The listed applicant is Polyganics B.V.,. It received FDA 510(k) clearance on 2006-10-18 under 510(k) number K062540. The device is classified under product code KCN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASOPORE EAR, MODELS ND04, ND05?

NASOPORE EAR, MODELS ND04, ND05 is a medical device that received FDA 510(k) clearance on 2006-10-18. The listed applicant is Polyganics B.V.,. The 510(k) number is K062540.

When did NASOPORE EAR, MODELS ND04, ND05 receive FDA 510(k) clearance?

NASOPORE EAR, MODELS ND04, ND05 received FDA 510(k) clearance on 2006-10-18, under 510(k) number K062540.

Who is the listed applicant for NASOPORE EAR, MODELS ND04, ND05?

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

What is the FDA product code for NASOPORE EAR, MODELS ND04, ND05?

The FDA product code for NASOPORE EAR, MODELS ND04, ND05 is KCN.

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 Polyganics B.V., 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.

K112267NEUROLAC(R) NERVE GUIDEK070715NASOPORE EARK052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZK050573NEUROLAC NERVE GUIDEK042811VIVOSORB SHEET, MODEL FS01K032115NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

View all 7 devices →

Related Devices (Code: KCN)

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.

K973578INVOTEC EAR TAMPON (WICK) W/STRINGInvotec International, Inc.K920357ULTRACELL EAR WICKUltracell Medical Technologies, Inc.K791059POPE OTO-WICK, STERILE & NON-STERILEXomed, 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.

↑