Question 1

Who is the manufacturer of UNIPOLAR NEEDLES?

Accepted Answer

Pajunk GmbH filed the 510(k) submission for UNIPOLAR NEEDLES (K000722).

Question 2

What is the FDA product code for UNIPOLAR NEEDLES?

Accepted Answer

BSP. It is classified under 21 CFR 868.5150 as a Class 2 device in the Anesthesiology panel.

Question 3

When was UNIPOLAR NEEDLES cleared by the FDA?

Accepted Answer

Mar 31, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for UNIPOLAR NEEDLES?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like UNIPOLAR NEEDLES?

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	K000722
Device Name	UNIPOLAR NEEDLES
Applicant	Pajunk GmbH
Product Code	BSP · Anesthesiology
Decision Date	Mar 31, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2

UNIPOLAR NEEDLES

Device Facts

Regulatory Classification

Identification