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510(k) K993591

BLADEWORKS DISPOSABLE ALK TUBING by Blade Works, Inc. — Product Code KYG

K993591 is an FDA 510(k) premarket notification submitted by Blade Works, Inc. for the device "BLADEWORKS DISPOSABLE ALK TUBING". The FDA issued a decision of Substantially Equivalent on December 28, 1999. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Blade Works, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1999
Date Received
October 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances by Blade Works, Inc.

  • K020079 — BLADEWORKS MICROKERATOME BLADE, MODEL 7061 (April 19, 2002)
  • K993225 — BLADEWORKS MICROKERATOME BLADE (March 20, 2000)

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K970161 — HEDGES CORNEAL WETTING PAK (March 25, 1997)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)
  • K940392 — PEREGRINE PIC MINIPULATOR (August 23, 1994)

FDA data resources