Question 1

Who is the manufacturer of ISPVAC TM?

Accepted Answer

Innovative Surgical Products, Inc. filed the 510(k) submission for ISPVAC TM (K802973).

Question 2

What is the FDA product code for ISPVAC TM?

Accepted Answer

GCY. It is classified under 21 CFR 878.4680 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was ISPVAC TM cleared by the FDA?

Accepted Answer

Dec 19, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for ISPVAC TM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ISPVAC TM?

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	K802973
Device Name	ISPVAC TM
Applicant	Innovative Surgical Products, Inc.
Product Code	GCY · General, Plastic Surgery
Decision Date	Dec 19, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4680
Device Class	Class 1

ISPVAC TM

Device Facts

Regulatory Classification

Identification