Product Code: NWJ FDA class 2 21 CFR 878.4494

Suture, Recombinant Technology

General, Plastic Surgery

The Suture, Recombinant Technology (product code NWJ) is a surgical suture manufactured using recombinant technology, intended for soft tissue approximation and ligation in general and plastic surgery procedures. It is classified as FDA Class 2, requiring a 510(k) premarket notification, and is regulated under 21 CFR 878.4494 within the General and Plastic Surgery specialty. This device carries an implant flag, as sutures are placed within the body during wound closure.

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510(k)s

FEI Numbers

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Basic Information

Product Code: NWJ
Device Class: FDA class 2
Regulation Number: 878.4494
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 9 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K211307	GalaSTITCH Absorbable Monofilament Suture	May 27, 2021	Substantially Equivalent	Tepha, Inc.
K132348	TEPHAFLEX BRAIDED SUTURE	Sep 05, 2013	Substantially Equivalent	Tepha, Inc.
K130422	PHANTOM FIBER BIOFIBER SUTURE	Apr 04, 2013	Substantially Equivalent	Tornier, Inc.
K122487	BIOFIBER SYTURE	Sep 17, 2012	Substantially Equivalent	Tornier, Inc.
K100876	AESCULAP MONOMAX ABSORBABLE SUTURE	Jul 14, 2010	Substantially Equivalent	Aesculap, Inc.
K082178	TEPHAFLEX ABSORBABLE SUTURE	Oct 30, 2008	Substantially Equivalent	Tepha, Inc.
K081099	TEPHAFLEX ABSORBABLE SUTURE	Jul 15, 2008	Substantially Equivalent	Tepha, Inc.
K072470	BIOELAST 5-0 SUTURE, MODEL 500100	Nov 16, 2007	Substantially Equivalent	Entrigue Surgical, Inc.
DEN060003	TEPHAFLEX ABSORBABLE SUTURE	Feb 08, 2007	Unknown	Tepha, Inc.