Home / 510(k) Clearances / K220891

510(k) K220891

Kahook Dual Blade Glide (KDB Glide) by New World Medical, Inc. — Product Code QUQ

K220891 is an FDA 510(k) premarket notification submitted by New World Medical, Inc. for the device "Kahook Dual Blade Glide (KDB Glide)". The FDA issued a decision of Substantially Equivalent on May 17, 2024. The device falls under product code QUQ (Knife, Intraocular Pressure Lowering), a Class II device regulated under 21 CFR 878.4400. New World Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2024
Date Received
March 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Intraocular Pressure Lowering
Device Class
Class II
Regulation Number
878.4400
Review Panel
OP
Submission Type

A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma

Other clearances by New World Medical, Inc.

  • K243503 — VIA360™ Surgical System (February 14, 2025)
  • K230975 — Ahmed® Glaucoma Valve Model FP7 (May 12, 2023)
  • K231051 — Ahmed® Glaucoma Valve Model FP8 (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)

FDA data resources