Question 1

Who is the manufacturer of SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE?

Accepted Answer

Somnus Medical Technologies, Inc. filed the 510(k) submission for SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE (K961133).

Question 2

What is the FDA product code for SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE?

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 SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE cleared by the FDA?

Accepted Answer

Jul 10, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE?

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	K961133
Device Name	SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE
Applicant	Somnus Medical Technologies, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE

Device Facts

Regulatory Classification

Identification