DISPOSABLE MICROSTAAR INJECTOR— 510(k) K940593

Name: FDA 510(k) clearance K940593
Creator: U.S. Food and Drug Administration
Published: 1994-09-19

Substantially Equivalent

Staar Sugical

FDA 510(k) clearance K940593 for DISPOSABLE MICROSTAAR INJECTOR, Substantially Equivalent on 1994-09-19. Applicant: Staar Sugical. Device class: 1.

Clearance details

Applicant: Staar Sugical
Product code: Code KYB
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 1994-02-09
Decision date: 1994-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYB

view all

K152357 — MicroSTAAR Injector System Cartridges2015-10-30
K081382 — DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK77862008-10-23
K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-22008-06-20
K070669 — IOL INJECTOR SET2007-11-01
K063155 — MONARCH III IOL DELIVERY SYSTEM2007-03-27

Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K940593

K-number listed on FDA's recall record

Z-1964-2016 — STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.Class II·Terminated·Staar Surgical Co.·20160502

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K940593.

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