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510(k) K023400

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT by Fci Ophthalmics, Inc. — Product Code HPZ

K023400 is an FDA 510(k) premarket notification submitted by Fci Ophthalmics, Inc. for the device "FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT". The FDA issued a decision of Substantially Equivalent on August 22, 2003. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Fci Ophthalmics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2003
Date Received
October 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Sphere
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Fci Ophthalmics, Inc.

  • K061404 — MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (August 7, 2006)
  • K061398 — SNUG PLUG PUNCTUM PLUG (July 11, 2006)
  • K041869 — SELF RETAINING BICANALICULUS INTUBATION SET (November 18, 2004)
  • K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (September 17, 2003)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K992294 — BIOCERAMIC ORBITAL IMPLANT (April 19, 2000)
  • K991238 — FCI CRAWFORD PROBE INTUBATION SETS (July 8, 1999)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K980822 — TITANIUM PEG SYSTEM (July 9, 1998)
  • K964774 — PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (December 20, 1996)

Other clearances for product code HPZ

  • K212741 — EZYPOR (June 24, 2022)
  • K123764 — DURETTE OCULAR IMPLANT (January 31, 2013)
  • K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX (November 2, 2011)
  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II (March 12, 2009)
  • K082850 — EYE SPHERES (February 27, 2009)
  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K070130 — ORBITAL RECONSTRUCTIVE IMPLANT (April 19, 2007)
  • K053298 — ALPHASPHERE ORBITAL IMPLANT (May 9, 2006)

FDA data resources