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510(k) K950599

STORS SCLERAL SPONGE II (LINCOFF DESIGN) by Storz Ophthalmics, Inc. — Product Code HQX

K950599 is an FDA 510(k) premarket notification submitted by Storz Ophthalmics, Inc. for the device "STORS SCLERAL SPONGE II (LINCOFF DESIGN)". The FDA issued a decision of Substantially Equivalent on March 2, 1995. The device falls under product code HQX (Implant, Orbital, Extra-Ocular), a Class II device regulated under 21 CFR 886.3340. Storz Ophthalmics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1995
Date Received
February 9, 1995
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 Storz Ophthalmics, Inc.

  • K884060 — MEDITEC QL-15 ND:YAG LASER (November 4, 1988)

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)
  • 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