Infusion Cannula

FDA 510(k) K831192 · Medical Instrument Development Laboratories, Inc.

Substantially Equivalent

510(k) numberK831192

Submission

Device name
Infusion Cannula
Applicant
Medical Instrument Development Laboratories, Inc.
Mchenry, IL, US
Received
April 12, 1983
Decision date
June 30, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HMX – Cannula, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HMX

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K010305Weiss Retinal CannulaHMX · Traditional Micron Surgical, Inc.05/02/2001SE
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K970873Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)HMX · Traditional American Medical Devices, Inc.05/20/1997SE
K943932Steriseal Ophthalmic CannulaHMX · Traditional Pharma-Plast, Ltd.01/18/1995SE
K942403Infusion CannulaHMX · Traditional Microsurgical Technology, Inc.08/17/1994SE
K934844Inter Tip THMX · Traditional Microsurgical Technology, Inc.04/19/1994SE
K930113Kirwan Irrigation/Aspiration HandpieceHMX · Traditional Kirwan Surgical Products, Inc.02/17/1994SE
K921488Aspirating Endo Ocular Probe W/IlluminationHMX · Traditional Surgical Technologies, Inc.05/07/1992SE
K915074Irrigator/Aspirator ProbeHMX · Traditional Biomedical Dynamics, Inc.02/05/1992SE
K904074Vitreoretinal Infusion CannulaHMX · Traditional Visitec Co.02/26/1991SE

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Questions and answers

When was Infusion Cannula cleared by the FDA?

Infusion Cannula (K831192) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 79 days after the submission was received.

What is the product code of K831192?

The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.