Question 1

Who is the manufacturer of SINGLE USE MONOPOLAR HAND CONTROL PENCIL?

Accepted Answer

Davol, Inc. filed the 510(k) submission for SINGLE USE MONOPOLAR HAND CONTROL PENCIL (K791137).

Question 2

What is the FDA product code for SINGLE USE MONOPOLAR HAND CONTROL PENCIL?

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 SINGLE USE MONOPOLAR HAND CONTROL PENCIL cleared by the FDA?

Accepted Answer

Jul 24, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for SINGLE USE MONOPOLAR HAND CONTROL PENCIL?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SINGLE USE MONOPOLAR HAND CONTROL PENCIL?

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	K791137
Device Name	SINGLE USE MONOPOLAR HAND CONTROL PENCIL
Applicant	Davol, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 24, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

SINGLE USE MONOPOLAR HAND CONTROL PENCIL

Device Facts

Regulatory Classification

Identification