Question 1

Who is the manufacturer of DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

Accepted Answer

Class A Ent. filed the 510(k) submission for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K912783).

Question 2

What is the FDA product code for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

Accepted Answer

GXZ. It is classified under 21 CFR 882.1350 as a Class 2 device in the Neurology panel.

Question 3

When was DISPOSABLE MONOPOLAR NEEDLE ELECTRODE cleared by the FDA?

Accepted Answer

Feb 5, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DISPOSABLE MONOPOLAR NEEDLE 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	K912783
Device Name	DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
Applicant	Class A Ent.
Product Code	GXZ · Neurology
Decision Date	Feb 5, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1350
Device Class	Class 2

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

Device Facts

Regulatory Classification

Identification