Question 1

Who is the manufacturer of SC TIP CLEANER?

Accepted Answer

Nsi filed the 510(k) submission for SC TIP CLEANER (K120581).

Question 2

What is the FDA product code for SC 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 SC TIP CLEANER cleared by the FDA?

Accepted Answer

Jun 29, 2012 (decision: SESE).

Question 4

What is the regulatory pathway for SC TIP CLEANER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SC 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	K120581
Device Name	SC TIP CLEANER
Applicant	Nsi
Product Code	GEI · General, Plastic Surgery
Decision Date	Jun 29, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

SC TIP CLEANER

Device Facts

Regulatory Classification

Identification