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510(k) K983581

OCU-GUARD AND OCU-GUARD SUPPLE by Bio-Vascular, Inc. — Product Code HQX

K983581 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "OCU-GUARD AND OCU-GUARD SUPPLE". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code HQX (Implant, Orbital, Extra-Ocular), a Class II device regulated under 21 CFR 886.3340. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1998
Date Received
October 13, 1998
Clearance Type
Special
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 Bio-Vascular, Inc.

  • K002233 — BVI SLING (October 13, 2000)
  • K992537 — PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND (February 22, 2000)
  • K983602 — CV PERI-GUARD AND VASCU-GUARD (November 12, 1998)
  • K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, P (October 9, 1998)
  • K981624 — FLO-THRU (August 4, 1998)
  • K982282 — DURA-GUARD - DURAL REPAIR PATCH (July 30, 1998)
  • K971726 — CV PERI-GUARD - CARDIOVASCULAR PATCH (April 10, 1998)
  • K973706 — DURA-GUARD-DURAL REPAIR PATCH (December 24, 1997)
  • K973552 — OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP (December 16, 1997)
  • K971048 — PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT (May 9, 1997)

Other clearances for product code HQX

  • K023481 — MICROVISION SCLERAL BUCKLING COMPONENTS (January 8, 2003)
  • 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)
  • K900930 — SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (May 15, 1990)

FDA data resources