Question 1

Who is the manufacturer of HEMOSTAT/STIMULATOR PROBE?

Accepted Answer

Rln Systems, Inc. filed the 510(k) submission for HEMOSTAT/STIMULATOR PROBE (K895676).

Question 2

What is the FDA product code for HEMOSTAT/STIMULATOR PROBE?

Accepted Answer

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

Question 3

When was HEMOSTAT/STIMULATOR PROBE cleared by the FDA?

Accepted Answer

Dec 8, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for HEMOSTAT/STIMULATOR PROBE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HEMOSTAT/STIMULATOR PROBE?

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	K895676
Device Name	HEMOSTAT/STIMULATOR PROBE
Applicant	Rln Systems, Inc.
Product Code	ETN · Ear, Nose, Throat
Decision Date	Dec 8, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

HEMOSTAT/STIMULATOR PROBE

Device Facts

Regulatory Classification

Identification