Infusion Cannulam

FDA 510(k) K852758 · Precision Medical Instruments, Inc.

Substantially Equivalent

510(k) numberK852758

Submission

Device name
Infusion Cannulam
Applicant
Precision Medical Instruments, Inc.
Belvedere, CA, US
Received
June 28, 1985
Decision date
August 1, 1985
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

510(k)DeviceApplicantDecision
K010305Weiss Retinal CannulaHMX · Traditional Micron Surgical, Inc.05/02/2001SE
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

More from Visitec Co.

510(k)DeviceDecision
K832560Aspirating Handle W/Backflushing Capab · Traditional 01/04/1984SE
K830037Extension Handle for Acutome ProbeHQE · Traditional 04/06/1983SE
K791212Vitrectomy Integrating Tray Ocutome/FragHQE · Traditional 08/10/1979SE

Questions and answers

When was Infusion Cannulam cleared by the FDA?

Infusion Cannulam (K852758) received a 510(k) decision of Substantially Equivalent on August 1, 1985, 34 days after the submission was received.

What is the product code of K852758?

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