Question 1

Who is the manufacturer of TUBING CONNECTORS?

Accepted Answer

First Industries, Inc. filed the 510(k) submission for TUBING CONNECTORS (K810652).

Question 2

What is the FDA product code for TUBING CONNECTORS?

Accepted Answer

BYX. It is classified under 21 CFR 868.5860 as a Class 1 device in the Anesthesiology panel.

Question 3

When was TUBING CONNECTORS cleared by the FDA?

Accepted Answer

Mar 31, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for TUBING CONNECTORS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TUBING CONNECTORS?

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	K810652
Device Name	TUBING CONNECTORS
Applicant	First Industries, Inc.
Product Code	BYX · Anesthesiology
Decision Date	Mar 31, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5860
Device Class	Class 1

TUBING CONNECTORS

Device Facts

Regulatory Classification

Identification