Polyform Synthetic Mesh

Q: What is the product code of K171271?

The FDA product code is OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a Class II (moderate risk) device regulated under 21 CFR 878.3300.

FDA 510(k) K171271 · Boston Scientific Corporation

Substantially Equivalent

510(k) numberK171271

Submission

Device name: Polyform Synthetic Mesh
Applicant: Boston Scientific Corporation
Marlboro, MA, US
Received: May 1, 2017
Decision date: December 15, 2017
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.3300
Specialty: General, Plastic Surgery
Implant: Yes

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

Other 510(k)s with product code OTO

510(k)	Device	Applicant	Decision
K150023	Vertessa Lite Y-MeshOTO · Traditional	Caldera Medical, Inc.	04/06/2015SE
K150016	Vertessa LiteOTO · Traditional	Caldera Medical, Inc.	04/06/2015SE
K140116	Restorelle Y Contour MeshOTO · Special	Coloplast A/S	02/12/2014SE
K132061	Restorelle M, Restorelle XLOTO · Special	Coloplast Corp.	08/02/2013SE
K123028	Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshOTO · Traditional	Caldera Medical, Inc.	04/25/2013SE
K123914	Restorelle Y ContourOTO · Special	Coloplast A/S	03/05/2013SE
K123337	Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMOTO · Traditional	Caldera Medical	02/21/2013SE
K122968	Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015OTO · Traditional	Coloplast Corp.	12/18/2012SE
K122794	Upsylon Y MeshOTO · Traditional	Boston Scientific Corp	12/18/2012SE
K122440	Restorelle LOTO · Traditional	Coloplast Corp.	11/19/2012SE

More from Coloplast Corp.

510(k)	Device	Decision
K262151	SpaceOAR Flex SystemOVB · Traditional	09/11/2026SE
K262460	Rezum SystemKNS · Traditional	09/03/2026SE
K261153	LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional	08/26/2026SE
K253692	AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional	08/21/2026SE
K262406	EluPro Antibiotic-Eluting BioEnvelopeFTM · Special	08/12/2026SE
K261915	Navigator Flex Ureteral Access Sheath SetFED · Traditional	08/04/2026SE
K262462	TheraSphere 360 Y-90 Management PlatformLLZ · Special	07/24/2026SE
K262165	FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special	07/24/2026SE
K261488	OBSIDIO Conformable EmbolicKRD · Traditional	07/24/2026SE
K261978	WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special	07/10/2026SE

Questions and answers

When was Polyform Synthetic Mesh cleared by the FDA?

Polyform Synthetic Mesh (K171271) received a 510(k) decision of Substantially Equivalent on December 15, 2017, 228 days after the submission was received.

What is the product code of K171271?

The FDA product code is OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a Class II (moderate risk) device regulated under 21 CFR 878.3300.