Question 1

Who is the manufacturer of HIGH TEMPERATURE CAUTERY 5 LOOP?

Accepted Answer

Aaron Medical Industries filed the 510(k) submission for HIGH TEMPERATURE CAUTERY 5 LOOP (K945759).

Question 2

What is the FDA product code for HIGH TEMPERATURE CAUTERY 5 LOOP?

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 HIGH TEMPERATURE CAUTERY 5 LOOP cleared by the FDA?

Accepted Answer

Jan 30, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for HIGH TEMPERATURE CAUTERY 5 LOOP?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HIGH TEMPERATURE CAUTERY 5 LOOP?

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	K945759
Device Name	HIGH TEMPERATURE CAUTERY 5 LOOP
Applicant	Aaron Medical Industries
Product Code	GEI · General, Plastic Surgery
Decision Date	Jan 30, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

HIGH TEMPERATURE CAUTERY 5 LOOP

Device Facts

Regulatory Classification

Identification