510(k) K133356 · GAW Suture, Nonabsorbable, Synthetic, Polypropylene

PROLENE POLYPROPYLENE NONABSORBABLE SUTURE

Applicant	ETHICON, Inc., Somerville NJ, US
Decision	Substantially Equivalent, Dec 6, 2013
Received	Oct 31, 2013
Type	Special
FDA record	Open on fda.gov

Recalls that name K133356

Date	Firm and product	Code	Linked 510(k)
Apr 3, 2025	Ethicon Endo Surgery, LLC PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM Open, Classified	NEW	None listed
Feb 4, 2025	Ethicon, LLC PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophtha Open, Classified	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 Terminated	GAW	None listed
May 7, 2018	Ethicon, Inc. PRONOVA SUTURE BLUE 122CM M1.5, D10189 Terminated	GAW	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.