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IScience Interventional Ophthalmic Microcatheter

by Iscience Interventional

510(k) K080067

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080067 Date18 Jul 2008ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0011-2019 FDA Class II initiated 11 Jan 2018 on shared 510(k) K080067

    Sterility failure found in one of the units in the lot.

    • Terminated Z-2590-2014 FDA Class II initiated 6 Aug 2014 on shared 510(k) K080067

    One lot may not have been properly sealed, resulting in a non-sterile device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MPA
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IScience Interventional Ophthalmic Microcatheter is a medical device used in ophthalmic procedures for delivering site-specific therapies via physiological routes of access. It is part of a system that enables minimally invasive ophthalmic procedures, including ASAT and PSAT, utilizing microcatheter and guidance technologies.

This device is supplied as a single-use or reusable product, depending on the specific model, and is available in various sizes. It is MRI compatible and has received FDA 510(k) clearance with the product code MPA. The device is manufactured by Iscience Interventional and is intended for use in interventional ophthalmology procedures.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the IScience Interventional Ophthalmic Microcatheter used for?

    The IScience Interventional Ophthalmic Microcatheter is used in ophthalmic procedures for delivering site-specific therapies via physiological routes of access. It enables minimally invasive ophthalmic procedures including ASAT and PSAT utilizing microcatheter and guidance technologies.

  • Is the IScience Interventional Ophthalmic Microcatheter single-use or reusable?

    The IScience Interventional Ophthalmic Microcatheter is supplied as either a single-use or reusable product depending on the specific model. The availability of both options allows clinicians to choose based on their procedural needs and institutional policies.

  • What sizes and models of the IScience Interventional Ophthalmic Microcatheter are available?

    The IScience Interventional Ophthalmic Microcatheter is available in various sizes to accommodate different clinical requirements. The specific sizes and models are determined by the manufacturer based on the intended use in various ophthalmic procedures.

  • What regulatory approvals does the IScience Interventional Ophthalmic Microcatheter have?

    The IScience Interventional Ophthalmic Microcatheter has received FDA 510(k) clearance with the product code MPA. It is classified as a Class 2 device and is MRI compatible, making it suitable for use in interventional ophthalmology procedures requiring imaging guidance.