Question 1

Who is the manufacturer of MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD?

Accepted Answer

Electroscope, Inc. filed the 510(k) submission for MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD (K912780).

Question 2

What is the FDA product code for MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD?

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 MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD cleared by the FDA?

Accepted Answer

Dec 30, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD?

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	K912780
Device Name	MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD
Applicant	Electroscope, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Dec 30, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD

Device Facts

Regulatory Classification

Identification