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510(k) K231051

Ahmed® Glaucoma Valve Model FP8 by New World Medical, Inc. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2023
Date Received
April 13, 2023
Clearance Type
Special
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 New World Medical, Inc.

  • K243503 — VIA360™ Surgical System (February 14, 2025)
  • K220891 — Kahook Dual Blade Glide (KDB Glide) (May 17, 2024)
  • K230975 — Ahmed® Glaucoma Valve Model FP7 (May 12, 2023)
  • K211680 — Streamline Surgical System (October 8, 2021)
  • K182518 — AHMED ClearPath Glaucoma Drainage Device (January 18, 2019)
  • K171451 — Ahmed Glaucoma Valve Model FP8 (August 8, 2017)
  • K162060 — Ahmed Glaucoma Valve (October 24, 2016)
  • K060644 — AHMED GLAUCOMA VALVE, MODEL M4 (September 18, 2006)
  • K991072 — AHMED GLAUCOMA VALVE IMPLANT (July 13, 1999)
  • K980657 — AHMED GLAUCOMA VALVE, MODEL S3 (April 20, 1998)

Other clearances for product code KYF

  • K230975 — Ahmed® Glaucoma Valve Model FP7 (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)
  • K030350 — EXPRESS MINI GLAUCOMA SHUNT (March 13, 2003)