OTN
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 65
Adverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OTN
- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K222293 — ArcSP Suprapubic Sling System
- K222468 — ArcTO Transobturator Sling System
- K211975 — 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
- K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K210087 — Athena Surgical RMUS System
- K201686 — 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
- K183134 — ArcTV Transvaginal Sling System
- K162201 — Desara TV, Desara Blue TV
- K140843 — DESARA BLUE OV, DESARA BLUE SS
- K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
- K132655 — RETROARC RETROPUBIC SLING SYSTEM
- K132069 — DESARA MESH, DESARA BLUE
- K132054 — GYNECARE TVT EXACT CONTINENCE SYSTEM
- K121928 — DESARA SL
- K121754 — BLUE SUI SLING
- K103022 — KIM
- K112609 — DESARA MESH
- K111219 — GMD UNIVERSAL URINARY INCONTINENCE SLING
- K111233 — SUPRIS RETROPUBIC SLING SYSTEM
- K100936 — GYNECARE TVT ABBREVO CONTINENCE SYSTEM
- K101440 — GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
- K101169 — DESARA MESH MODEL: CAL-DS01
- K093747 — ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
- K100485 — GYNECARE TVT EXACT CONTINENCE SYSTEM
- K092203 — OMNISURE URETHRAL SLING, MODEL OTK52
- K083471 — GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
- K081613 — SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
- K072456 — DESARA MESH SLING, MODEL CAL-DS01
- K073647 — MINITAPE EXTRA URETHRAL SLING
- K070073 — ALIGN URETHRAL SUPPORT SYSTEM
- K063713 — AMS SMART SLING SYSTEM
- K050516 — T-SLING
- K053296 — MENTOR ARIS SUPRAPUBIC SURGICAL KIT
- K052175 — I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
- K051533 — I-STOP
- K051530 — MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.
- K050148 — MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
- K042592 — INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
- K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
- K041948 — SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
- K041176 — URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
- K040787 — MODIFICATION TO SURGICAL MESH POLYMERIC
- K040538 — BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
- K033310 — REMEEX SYSTEM FOR URINARY INCONTINENCE
- K033691 — SAFYRE VS AND SAFYRE T
- K033568 — GYNECARE TVT OBTURATOR SYSTEM
- K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE
- K030123 — BIOARC SP SLING KIT
- K023516 — MONARC SLING SYSTEM
- K021263 — MODIFICATION TO SPARC SLING SYSTEM
- K020705 — SIIS#1 TISSUE SUSPENSION SYSTEM
- K020110 — MODIFICATION TO TRELEX MESH SURGICAL MESH
- K020663 — MODIFICATION TO SPARC SLING SYSTEM
- K020007 — SAFYRE SLING SYSTEM
- K012628 — GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
- K013355 — SPARC SLING SYSTEM
- K012949 — URETEX SUP PUBOURETHRAL SLING
- K011251 — SPARC SLING SYSTEM
- K982042 — ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
- K980482 — TRIANGLE SLING
- K974098 — PUBOUURETHRAL SLING
- K973022 — ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
- K972651 — IN-SLING
- K960101 — ISLAND BIOSURGICAL BOLSTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.