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FDA 510(k)

POREX(TM) EYE SPHERE IMPLANT

K-Number: K863943 · 1987-02-27

ApplicantPorex Medical
Decision Date1987-02-27
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

POREX(TM) EYE SPHERE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Porex Medical. It received FDA 510(k) clearance on 1987-02-27 under 510(k) number K863943. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POREX(TM) EYE SPHERE IMPLANT?

POREX(TM) EYE SPHERE IMPLANT is a medical device that received FDA 510(k) clearance on 1987-02-27. The listed applicant is Porex Medical. The 510(k) number is K863943.

When did POREX(TM) EYE SPHERE IMPLANT receive FDA 510(k) clearance?

POREX(TM) EYE SPHERE IMPLANT received FDA 510(k) clearance on 1987-02-27, under 510(k) number K863943.

Who is the listed applicant for POREX(TM) EYE SPHERE IMPLANT?

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

What is the FDA product code for POREX(TM) EYE SPHERE IMPLANT?

The FDA product code for POREX(TM) EYE SPHERE IMPLANT is HPZ.

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 IMPLANTK870257POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.K870154POREX(TM) TISSUE EXPANDER

View all 15 devices →

Related Devices (Code: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, 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.

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