Question 1

Who is the manufacturer of TEFLON PLEDGET SUTURE BUTTRESS?

Accepted Answer

ETHICON, Inc. filed the 510(k) submission for TEFLON PLEDGET SUTURE BUTTRESS (K811872).

Question 2

What is the FDA product code for TEFLON PLEDGET SUTURE BUTTRESS?

Accepted Answer

DXZ. It is classified under 21 CFR 870.3470 as a Class 2 device in the Cardiovascular panel.

Question 3

When was TEFLON PLEDGET SUTURE BUTTRESS cleared by the FDA?

Accepted Answer

Aug 12, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for TEFLON PLEDGET SUTURE BUTTRESS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TEFLON PLEDGET SUTURE BUTTRESS?

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	K811872
Device Name	TEFLON PLEDGET SUTURE BUTTRESS
Applicant	ETHICON, Inc.
Product Code	DXZ · Cardiovascular
Decision Date	Aug 12, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3470
Device Class	Class 2

TEFLON PLEDGET SUTURE BUTTRESS

Device Facts

Regulatory Classification

Identification