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510(k) K062252

MOLTENO3 by Iop, Inc. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2006
Date Received
August 3, 2006
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)
  • 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)
  • K890598 — MOLTENO IMPLANT (February 27, 1989)

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  • 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)
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  • K152996 — Molteno3 Glaucoma Implant (December 17, 2015)
  • K060644 — AHMED GLAUCOMA VALVE, MODEL M4 (September 18, 2006)
  • K030350 — EXPRESS MINI GLAUCOMA SHUNT (March 13, 2003)