GORE SPHEREX IMPLANT— 510(k) K962241

Name: FDA 510(k) clearance K962241
Creator: U.S. Food and Drug Administration
Published: 1996-08-22

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K962241 for GORE SPHEREX IMPLANT, Substantially Equivalent on 1996-08-22. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Product code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 1996-06-11
Decision date: 1996-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HPZ

view all

K212741 — EZYPOR2022-06-24
K123764 — DURETTE OCULAR IMPLANT2013-01-31
K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX2011-11-02
K112176 — SILICONE SPHERES2011-09-15
K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II2009-03-12

More clearances from W. L. Gore & Associates, Inc.

view all

K250410 — GORE® Tri-Lobe Balloon Catheter2025-06-02
K240083 — GORE® PROPATEN® Vascular Graft2024-03-01
K232312 — GORE® PROPATEN® Vascular Graft2024-01-09
K233551 — GORE® ACUSEAL Vascular Graft2023-12-19
K231505 — GORE® ACUSEAL Vascular Graft2023-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.