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FDA 510(k)

POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT

K-Number: K863946 · 1987-02-27

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

Device Summary

POREX(TM) EXTRA-OCULAR ORBITAL 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 K863946. The device is classified under product code HQX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT?

POREX(TM) EXTRA-OCULAR ORBITAL 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 K863946.

When did POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT receive FDA 510(k) clearance?

POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT received FDA 510(k) clearance on 1987-02-27, under 510(k) number K863946.

Who is the listed applicant for POREX(TM) EXTRA-OCULAR ORBITAL 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) EXTRA-OCULAR ORBITAL IMPLANT?

The FDA product code for POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT is HQX.

Related Clinical Trials

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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 INSTRUMENTSK863943POREX(TM) EYE SPHERE IMPLANTK870257POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.K870154POREX(TM) TISSUE EXPANDER

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Related Devices (Code: HQX)

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.

K023481MICROVISION SCLERAL BUCKLING COMPONENTSMicrovision, Inc.K983581OCU-GUARD AND OCU-GUARD SUPPLEBio-Vascular, Inc.K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGESFci Ophthalmics, Inc.K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGESFci Ophthalmics, Inc.K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSMira, Inc.K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)Storz Ophthalmics, 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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