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FDA 510(k)

LENS INSERTION GLIDE

K-Number: K840694 · 1984-05-09

ApplicantInnovative Surgical Products, Inc.
Decision Date1984-05-09
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENS INSERTION GLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Products, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K840694. The device is classified under product code KYB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENS INSERTION GLIDE?

LENS INSERTION GLIDE is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Innovative Surgical Products, Inc.. The 510(k) number is K840694.

When did LENS INSERTION GLIDE receive FDA 510(k) clearance?

LENS INSERTION GLIDE received FDA 510(k) clearance on 1984-05-09, under 510(k) number K840694.

Who is the listed applicant for LENS INSERTION GLIDE?

The FDA 510(k) record lists Innovative Surgical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LENS INSERTION GLIDE?

The FDA product code for LENS INSERTION GLIDE is KYB.

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Other records listing Innovative Surgical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K843041HESLIN DISPOS. TUBING SETK840693DISPOSABLE SCLERAL GLOBE PLUGK840695PHACOEMULSIFICATION KITSK841072IRRIGATION, ASPIRATION TUBING SETSK832235DISPOSABLE VITRECTOMY HANDPIECEK821496DISPOSABLE IRRIGA/ASPIR. SYSTEM

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Related Devices (Code: KYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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