Question 1

Who is the manufacturer of LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES?

Accepted Answer

Birtcher Medical Systems, Inc. filed the 510(k) submission for LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES (K944681).

Question 2

What is the FDA product code for LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES?

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 LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES cleared by the FDA?

Accepted Answer

Dec 22, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES?

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	K944681
Device Name	LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES
Applicant	Birtcher Medical Systems, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Dec 22, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES

Device Facts

Regulatory Classification

Identification