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510(k) K162060

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2016
Date Received
July 26, 2016
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 New World Medical, Inc.

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  • K220891 — Kahook Dual Blade Glide (KDB Glide) (May 17, 2024)
  • K231051 — Ahmed® Glaucoma Valve Model FP8 (May 12, 2023)
  • 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)
  • 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

  • K231051 — Ahmed® Glaucoma Valve Model FP8 (May 12, 2023)
  • 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)
  • 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)