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510(k) K981116

SOVEREIGN CATARACT EXTRACTION SYSTEM by Allergan, Inc. — Product Code KYG

K981116 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "SOVEREIGN CATARACT EXTRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 19, 1998. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Allergan, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1998
Date Received
March 27, 1998
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 Allergan, Inc.

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  • K193589 — TrueTear Intranasal Tear Neurostimulator (August 31, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
  • K143354 — Natrelle 133 Plus Tissue Expander (August 20, 2015)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)
  • K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS (July 9, 2009)

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)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • 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