Question 1

Who is the manufacturer of O-R-EZ TIP CLEANER?

Accepted Answer

O-R-Ez, Inc. filed the 510(k) submission for O-R-EZ TIP CLEANER (K942957).

Question 2

What is the FDA product code for O-R-EZ TIP CLEANER?

Accepted Answer

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was O-R-EZ TIP CLEANER cleared by the FDA?

Accepted Answer

Jul 19, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for O-R-EZ TIP CLEANER?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like O-R-EZ TIP CLEANER?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K942957
Device Name	O-R-EZ TIP CLEANER
Applicant	O-R-Ez, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 19, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

O-R-EZ TIP CLEANER

Device Facts

Regulatory Classification

Identification