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Irrigator/Aspirator Probe

by Biomedical Dynamics, Inc.

510(k) K915074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

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

Overview

The IRRIGATOR/ASPIRATOR PROBE is a FDA-approved, ophthalmic cannula designed for the precise irrigation and aspiration of ocular tissues in medical procedures. This device features a unique, ergonomic design with adjustable suction control, allowing for customized comfort and efficacy. The IRRIGATOR/ASPIRATOR PROBE has been extensively tested in various clinical settings to demonstrate its reliability and safety for use in ophthalmic applications.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915074 Date5 Feb 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
HMX
Device Class
Class I
Regulation
21 CFR Part 886.4350
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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