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FDA 510(k)

POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.

K-Number: K870257 · 1987-02-24

ApplicantPorex Medical
Decision Date1987-02-24
Product Code
DecisionSubstantially Equivalent

Device Summary

POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. is the device name listed in this FDA 510(k) record. The listed applicant is Porex Medical. It received FDA 510(k) clearance on 1987-02-24 under 510(k) number K870257. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.?

POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. is a medical device that received FDA 510(k) clearance on 1987-02-24. The listed applicant is Porex Medical. The 510(k) number is K870257.

When did POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. receive FDA 510(k) clearance?

POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. received FDA 510(k) clearance on 1987-02-24, under 510(k) number K870257.

Who is the listed applicant for POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.?

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

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 Porex Medical 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.

K872791POREX NERVE LOCATORK873044POREX OTOLOGY INSTRUMENTSK872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSK863946POREX(TM) EXTRA-OCULAR ORBITAL IMPLANTK863943POREX(TM) EYE SPHERE IMPLANTK870154POREX(TM) TISSUE EXPANDER

View all 15 devices →

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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