510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981116Substantially Equivalent

Sovereign Cataract Extraction System

Allergan, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981116 is the FDA 510(k) clearance record for SOVEREIGN CATARACT EXTRACTION SYSTEM, a class I device, cleared for Allergan, Inc. on under FDA product code KYG (Device, Irrigation, Ocular Surgery). FDA records list 39 510(k) clearances for Allergan, Inc., from to . As of , FDA records show one recall naming K981116.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KYG Device, Irrigation, Ocular Surgery
Regulation
21 CFR 886.4360
Device class
Class I
Review panel
Ophthalmic
Applicant
Allergan, Inc. 2525 Dupont Dr., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code KYG

Trailing 12 months

FDA records hold no clearances under product code KYG in the trailing twelve months.

FDA records show no clearances under product code KYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260