Question 1

Who is the manufacturer of LAPAROSCOPIC ELECTROSURGICAL DEVICE?

Accepted Answer

Everest Medical Corp. filed the 510(k) submission for LAPAROSCOPIC ELECTROSURGICAL DEVICE (K904993).

Question 2

What is the FDA product code for LAPAROSCOPIC ELECTROSURGICAL DEVICE?

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 LAPAROSCOPIC ELECTROSURGICAL DEVICE cleared by the FDA?

Accepted Answer

Jan 25, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for LAPAROSCOPIC ELECTROSURGICAL DEVICE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LAPAROSCOPIC ELECTROSURGICAL DEVICE?

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	K904993
Device Name	LAPAROSCOPIC ELECTROSURGICAL DEVICE
Applicant	Everest Medical Corp.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jan 25, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

LAPAROSCOPIC ELECTROSURGICAL DEVICE

Device Facts

Regulatory Classification

Identification