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FDA 510(k)

THE EXPANDACELL SINUS PACK

K-Number: K935724 · 1994-05-12

ApplicantDenver Splint Co.
Decision Date1994-05-12
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

THE EXPANDACELL SINUS PACK is the device name listed in this FDA 510(k) record. The listed applicant is Denver Splint Co.. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K935724. 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 THE EXPANDACELL SINUS PACK?

THE EXPANDACELL SINUS PACK is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Denver Splint Co.. The 510(k) number is K935724.

When did THE EXPANDACELL SINUS PACK receive FDA 510(k) clearance?

THE EXPANDACELL SINUS PACK received FDA 510(k) clearance on 1994-05-12, under 510(k) number K935724.

Who is the listed applicant for THE EXPANDACELL SINUS PACK?

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

What is the FDA product code for THE EXPANDACELL SINUS PACK?

The FDA product code for THE EXPANDACELL SINUS 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 Denver Splint Co. 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.

K940798SHIPPERT PRESSURE BANDAGEK940133THE EXPANDACELL EAR PACKK922062THE DENVER CAUTERY

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.

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