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510(k) K863946

POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT by Porex Medical — Product Code HQX

K863946 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT". The FDA issued a decision of Substantially Equivalent on February 27, 1987. The device falls under product code HQX (Implant, Orbital, Extra-Ocular), a Class II device regulated under 21 CFR 886.3340. Porex Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1987
Date Received
October 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Orbital, Extra-Ocular
Device Class
Class II
Regulation Number
886.3340
Review Panel
OP
Submission Type

Other clearances by Porex Medical

  • K872791 — POREX NERVE LOCATOR (October 20, 1987)
  • K873044 — POREX OTOLOGY INSTRUMENTS (September 4, 1987)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K863943 — POREX(TM) EYE SPHERE IMPLANT (February 27, 1987)
  • K870154 — POREX(TM) TISSUE EXPANDER (February 24, 1987)
  • K870182 — POREX(TM) MALAR IMPLANT (February 24, 1987)
  • K870257 — POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. (February 24, 1987)
  • K863941 — POREX(TM) PROSTHESIS, CHIN, INTERNAL (October 24, 1986)
  • K863942 — POREX(TM) NOSE PROSTHESIS (October 24, 1986)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)

Other clearances for product code HQX

  • K023481 — MICROVISION SCLERAL BUCKLING COMPONENTS (January 8, 2003)
  • K983581 — OCU-GUARD AND OCU-GUARD SUPPLE (November 6, 1998)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND S (October 28, 1996)
  • K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (June 5, 1996)
  • K950599 — STORS SCLERAL SPONGE II (LINCOFF DESIGN) (March 2, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K902308 — TAMCENAN OCULAR EXPLANTS AND BANDS (June 19, 1990)
  • K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (May 22, 1990)
  • K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (May 18, 1990)

FDA data resources