Question 1

Who is the manufacturer of FLEXTUBES:9, 20, 26?

Accepted Answer

Bourns Medical Systems, Inc. filed the 510(k) submission for FLEXTUBES:9, 20, 26 (K781428).

Question 2

What is the FDA product code for FLEXTUBES:9, 20, 26?

Accepted Answer

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

Question 3

When was FLEXTUBES:9, 20, 26 cleared by the FDA?

Accepted Answer

Sep 11, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for FLEXTUBES:9, 20, 26?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like FLEXTUBES:9, 20, 26?

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	K781428
Device Name	FLEXTUBES:9, 20, 26
Applicant	Bourns Medical Systems, Inc.
Product Code	BYX · Anesthesiology
Decision Date	Sep 11, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5860
Device Class	Class 1

FLEXTUBES:9, 20, 26

Device Facts

Regulatory Classification

Identification