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510(k) K890598

MOLTENO IMPLANT by Iop, Inc. — Product Code KYF

K890598 is an FDA 510(k) premarket notification submitted by Iop, Inc. for the device "MOLTENO IMPLANT". The FDA issued a decision of Substantially Equivalent on February 27, 1989. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Iop, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1989
Date Received
February 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type

Other clearances by Iop, Inc.

  • K090078 — KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (May 8, 2009)
  • K062252 — MOLTENO3 (September 27, 2006)
  • K053622 — SURGISIS OCULAR GRAFT (March 15, 2006)
  • K010852 — OSMED TISSUE EXPANDER (August 13, 2001)
  • K003646 — SUTUREGROOVE WEIGHT SIZING SET (February 22, 2001)
  • K994289 — SUTUREGROOVE (April 17, 2000)
  • K972143 — MOA BONE / M-SPHERE (October 16, 1997)
  • K902489 — MODIFIED MOLTENO(TM) IMPLANTS (August 14, 1990)

Other clearances for product code KYF

  • K230975 — Ahmed® Glaucoma Valve Model FP7 (May 12, 2023)
  • K231051 — Ahmed® Glaucoma Valve Model FP8 (May 12, 2023)
  • K220032 — iStent infinite Trabecular Micro-Bypass System, Model iS3 (August 2, 2022)
  • K182518 — AHMED ClearPath Glaucoma Drainage Device (January 18, 2019)
  • K171451 — Ahmed Glaucoma Valve Model FP8 (August 8, 2017)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
  • K162060 — Ahmed Glaucoma Valve (October 24, 2016)
  • K152996 — Molteno3 Glaucoma Implant (December 17, 2015)
  • K062252 — MOLTENO3 (September 27, 2006)
  • K060644 — AHMED GLAUCOMA VALVE, MODEL M4 (September 18, 2006)

FDA data resources