LENS INSERTION GLIDE— 510(k) K840694

Name: FDA 510(k) clearance K840694
Creator: U.S. Food and Drug Administration
Published: 1984-05-09

Substantially Equivalent

Innovative Surgical Products, Inc.

FDA 510(k) clearance K840694 for LENS INSERTION GLIDE, Substantially Equivalent on 1984-05-09. Applicant: Innovative Surgical Products, Inc.. Device class: 1.

Clearance details

Applicant: Innovative Surgical Products, Inc.
Product code: Code KYB
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 1984-02-16
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Innovative Surgical Products, Inc.

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K843041 — HESLIN DISPOS. TUBING SET1984-11-21
K840693 — DISPOSABLE SCLERAL GLOBE PLUG1984-05-22
K840695 — PHACOEMULSIFICATION KITS1984-05-22
K841072 — IRRIGATION, ASPIRATION TUBING SETS1984-03-29
K832235 — DISPOSABLE VITRECTOMY HANDPIECE1983-09-29

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 →

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