Question 1

Who is the manufacturer of ENTEC REFLEX WAND 55, MODEL E4055-00?

Accepted Answer

Arthrocare Corp. filed the 510(k) submission for ENTEC REFLEX WAND 55, MODEL E4055-00 (K000036).

Question 2

What is the FDA product code for ENTEC REFLEX WAND 55, MODEL E4055-00?

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 ENTEC REFLEX WAND 55, MODEL E4055-00 cleared by the FDA?

Accepted Answer

Feb 4, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for ENTEC REFLEX WAND 55, MODEL E4055-00?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ENTEC REFLEX WAND 55, MODEL E4055-00?

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	K000036
Device Name	ENTEC REFLEX WAND 55, MODEL E4055-00
Applicant	Arthrocare Corp.
Product Code	GEI · General, Plastic Surgery
Decision Date	Feb 4, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

ENTEC REFLEX WAND 55, MODEL E4055-00

Device Facts

Regulatory Classification

Identification