Question 1

Who is the manufacturer of G-T 1000?

Accepted Answer

G-T Products filed the 510(k) submission for G-T 1000 (K854020).

Question 2

What is the FDA product code for G-T 1000?

Accepted Answer

FTC. It is classified under 21 CFR 878.4630 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was G-T 1000 cleared by the FDA?

Accepted Answer

Nov 15, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for G-T 1000?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like G-T 1000?

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	K854020
Device Name	G-T 1000
Applicant	G-T Products
Product Code	FTC · General, Plastic Surgery
Decision Date	Nov 15, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4630
Device Class	Class 2

G-T 1000

Device Facts

Regulatory Classification

Identification