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)

EPISTAXIS NASAL PACK

K-Number: K971000 · 1997-05-14

ApplicantInvotec International, Inc.
Decision Date1997-05-14
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EPISTAXIS NASAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 1997-05-14 under 510(k) number K971000. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISTAXIS NASAL PACK?

EPISTAXIS NASAL PACK is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Invotec International, Inc.. The 510(k) number is K971000.

When did EPISTAXIS NASAL PACK receive FDA 510(k) clearance?

EPISTAXIS NASAL PACK received FDA 510(k) clearance on 1997-05-14, under 510(k) number K971000.

Who is the listed applicant for EPISTAXIS NASAL PACK?

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

What is the FDA product code for EPISTAXIS NASAL PACK?

The FDA product code for EPISTAXIS NASAL PACK is EMX.

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 Invotec International, 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.

K122040INVOTEC LARYNGEAL ELECTRODEK080740CLEARVIEW ENDOSCOPE COVERK030492TITANIUM OSSICULAR REPLACMENT SYSTEMK973580INVOTEC CLEAN PADK973578INVOTEC EAR TAMPON (WICK) W/STRINGK930114TRACHEOSTOMY T-TUBE

View all 16 devices →

Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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.

↑