SOVEREIGN CATARACT EXTRACTION SYSTEM— 510(k) K981116

Name: FDA 510(k) clearance K981116
Creator: U.S. Food and Drug Administration
Published: 1998-05-19

Substantially Equivalent

Allergan, Inc.

FDA 510(k) clearance K981116 for SOVEREIGN CATARACT EXTRACTION SYSTEM, Substantially Equivalent on 1998-05-19. Applicant: Allergan, Inc.. Device class: 1.

Clearance details

Applicant: Allergan, Inc.
Product code: Code KYG
Device class: Class 1
Regulation: 21 CFR 886.4360
Advisory panel: Ophthalmic
Date received: 1998-03-27
Decision date: 1998-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K980647 — EYE IRRIGATOR MODEL #20201998-05-15
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Recalls naming K981116

K-number listed on FDA's recall record

Z-0130-2024 — AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.Class II·Ongoing·B. Braun Medical, Inc.·20230926

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981116.

Data sourced from openFDA. This site is unofficial and independent of the FDA.