Autopole Regulator System

FDA 510(k) K924999 · Escalon Trek Medical

Substantially Equivalent

510(k) numberK924999

Submission

Device name
Autopole Regulator System
Applicant
Escalon Trek Medical
Skillmanl, NJ, US
Received
October 2, 1992
Decision date
December 24, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KYG – Device, Irrigation, Ocular Surgery
Device class
Class I (low risk)
Regulation
21 CFR 886.4360
Specialty
Ophthalmic

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Questions and answers

When was Autopole Regulator System cleared by the FDA?

Autopole Regulator System (K924999) received a 510(k) decision of Substantially Equivalent on December 24, 1992, 83 days after the submission was received.

What is the product code of K924999?

The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.