Chrysalis Intelligence · Product Codes · OTN

OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

General, Plastic Surgery · 7 clearances · 5 unique sponsors

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Device class

Class II

Regulation 878.3300

Total clearances

2020-09-17 → 2023-06-29

Last 12 months

Unique sponsors

Definition

What is Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.3300

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Most recent
Urocure, LLC	2	2022-09-21
Boston Scientific Corporation	2	2023-06-29
Caldera Medical, Inc.	1	2021-11-10
ETHICON, Inc.	1	2020-09-17
Athena Surgical, LLC	1	2021-04-12

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
57288	CPT	—	High	Urethral sling procedure, synthetic; OTN is synthetic mesh for female stress urinary incontinence via retropubic/transobturator placement
57289	CPT	—	High	Transobturator sling procedure; specific to transobturator approach for SUI

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2023-06-29	K231549	Boston Scientific Corporation	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
2022-09-21	K222293	Urocure, LLC	ArcSP Suprapubic Sling System
2022-09-15	K222468	Urocure, LLC	ArcTO Transobturator Sling System
2021-11-10	K211975	Caldera Medical, Inc.	Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
2021-07-21	K211223	Boston Scientific Corporation	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
2021-04-12	K210087	Athena Surgical, LLC	Athena Surgical RMUS System
2020-09-17	K201686	ETHICON, Inc.	GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide