Question 1

Who is the manufacturer of ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)?

Accepted Answer

Cytocare, Inc. filed the 510(k) submission for ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) (K954321).

Question 2

What is the FDA product code for ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)?

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 ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) cleared by the FDA?

Accepted Answer

Oct 13, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)?

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	K954321
Device Name	ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)
Applicant	Cytocare, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Oct 13, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)

Device Facts

Regulatory Classification

Identification