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FDA 510(k)

GORE SPHEREX IMPLANT

K-Number: K962241 · 1996-08-22

ApplicantW. L. Gore & Associates, Inc.
Decision Date1996-08-22
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GORE SPHEREX IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1996-08-22 under 510(k) number K962241. 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 GORE SPHEREX IMPLANT?

GORE SPHEREX IMPLANT is a medical device that received FDA 510(k) clearance on 1996-08-22. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K962241.

When did GORE SPHEREX IMPLANT receive FDA 510(k) clearance?

GORE SPHEREX IMPLANT received FDA 510(k) clearance on 1996-08-22, under 510(k) number K962241.

Who is the listed applicant for GORE SPHEREX IMPLANT?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE SPHEREX IMPLANT?

The FDA product code for GORE SPHEREX IMPLANT is HPZ.

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Other records listing W. L. Gore & Associates, Inc. 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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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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