Chrysalis Intelligence · Product Codes · OTN

OTN · Unclassified

7 clearances · 5 unique sponsors

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Device class
—
Regulation —
Total clearances
7
2020-09-17 → 2023-06-29
Last 12 months
0
Unique sponsors
5
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Boston Scientific Corporation 2 0 2023-06-29
Urocure, LLC 2 0 2022-09-21
Athena Surgical, LLC 1 0 2021-04-12
Caldera Medical, Inc. 1 0 2021-11-10
ETHICON, Inc. 1 0 2020-09-17
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.

CodeTypeDescriptionConfidenceRationale
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

DateK-numberSponsorDevice
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
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence