Question 1

Who is the manufacturer of EPINEED EPIDURAL NEEDLE?

Accepted Answer

Terumo Medical Corp. filed the 510(k) submission for EPINEED EPIDURAL NEEDLE (K832233).

Question 2

What is the FDA product code for EPINEED EPIDURAL NEEDLE?

Accepted Answer

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

Question 3

When was EPINEED EPIDURAL NEEDLE cleared by the FDA?

Accepted Answer

Aug 8, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for EPINEED EPIDURAL NEEDLE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EPINEED EPIDURAL NEEDLE?

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	K832233
Device Name	EPINEED EPIDURAL NEEDLE
Applicant	Terumo Medical Corp.
Product Code	BSP · Anesthesiology
Decision Date	Aug 8, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2

EPINEED EPIDURAL NEEDLE

Device Facts

Regulatory Classification

Identification