Weiss Retinal Cannula

FDA 510(k) K010305 · Micron Surgical, Inc.

Substantially Equivalent

510(k) numberK010305

Submission

Device name
Weiss Retinal Cannula
Applicant
Micron Surgical, Inc.
Margate, FL, US
Received
February 1, 2001
Decision date
May 2, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

510(k)DeviceApplicantDecision
K000457Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional Retinalabs.Com05/09/2000SE
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
K901618Ocular Infusion Cannula SystemHMX · Traditional Tamcenan Corp.05/31/1990SE

Questions and answers

When was Weiss Retinal Cannula cleared by the FDA?

Weiss Retinal Cannula (K010305) received a 510(k) decision of Substantially Equivalent on May 2, 2001, 90 days after the submission was received.

What is the product code of K010305?

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