FDA 510(k)

POREX NOSTRIL RETAINERS

K-Number: K981374 · 1998-07-02

Decision Date1998-07-02

Product CodeLYA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

POREX NOSTRIL RETAINERS is the device name listed in this FDA 510(k) record. The listed applicant is Porex Surgical, Inc.. It received FDA 510(k) clearance on 1998-07-02 under 510(k) number K981374. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POREX NOSTRIL RETAINERS?

POREX NOSTRIL RETAINERS is a medical device that received FDA 510(k) clearance on 1998-07-02. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K981374.

When did POREX NOSTRIL RETAINERS receive FDA 510(k) clearance?

POREX NOSTRIL RETAINERS received FDA 510(k) clearance on 1998-07-02, under 510(k) number K981374.

Who is the listed applicant for POREX NOSTRIL RETAINERS?

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

What is the FDA product code for POREX NOSTRIL RETAINERS?

The FDA product code for POREX NOSTRIL RETAINERS is LYA.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Porex Surgical, Inc. as applicant

K102184MEDPOR CONTAIN CAN IMPLANT K101835MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 K091807MEDPOR FIXATION SYSTEM K091120MEDPOR CONTAIN IMPLANT K083621MEDPOR CUSTOMIZED SURGICAL IMPLANT K071335MEDPOR ATTRACTOR IMPLANT

View all 19 devices →

Related Devices (Code: LYA)

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLC K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed K181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

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.