FDA Product Code
FDA Product Code OTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2023-06-29 | Special | PDF ↗ |
| K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | 2022-09-21 | Special | PDF ↗ |
| K222468 | ArcTO Transobturator Sling System | Urocure, LLC | 2022-09-15 | Special | PDF ↗ |
| 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 | Caldera Medical, Inc. | 2021-11-10 | Special | PDF ↗ |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2021-07-21 | Traditional | PDF ↗ |
| K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | 2021-04-12 | Traditional | PDF ↗ |
| 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 | ETHICON, Inc. | 2020-09-17 | Traditional | PDF ↗ |
| K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019-02-07 | Traditional | PDF ↗ |
| K162201 | Desara TV, Desara Blue TV | Caldera Medical, Inc. | 2017-01-11 | Traditional | PDF ↗ |
| K140843 | DESARA BLUE OV, DESARA BLUE SS | Caldera Medical | 2014-07-01 | Special | PDF ↗ |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | American Medical Systems | 2013-12-05 | Special | PDF ↗ |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | American Medical Systems, Inc. | 2013-11-20 | Traditional | PDF ↗ |
| K132069 | DESARA MESH, DESARA BLUE | Caldera Medical, Inc. | 2013-09-23 | Traditional | PDF ↗ |
| K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | 2013-08-23 | Special | PDF ↗ |
| K121928 | DESARA SL | Caldera Medical, Inc. | 2013-02-19 | Traditional | PDF ↗ |
| K121754 | BLUE SUI SLING | Boston Scientific Corp | 2012-10-10 | Traditional | PDF ↗ |
| K103022 | KIM | Neomedic International S.L. | 2011-12-20 | Traditional | PDF ↗ |
| K112609 | DESARA MESH | Caldera Medical, Inc. | 2011-09-30 | Special | PDF ↗ |
| K111219 | GMD UNIVERSAL URINARY INCONTINENCE SLING | Generic Medical Device, Inc. | 2011-06-30 | Traditional | PDF ↗ |
| K111233 | SUPRIS RETROPUBIC SLING SYSTEM | Coloplast A/S | 2011-06-24 | Special | PDF ↗ |
| K100936 | GYNECARE TVT ABBREVO CONTINENCE SYSTEM | ETHICON, Inc. | 2010-07-01 | Traditional | PDF ↗ |
| K101440 | GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 | Generic Medical Devices, Inc. | 2010-06-18 | Special | PDF ↗ |
| K101169 | DESARA MESH MODEL: CAL-DS01 | Caldera Medical, Inc. | 2010-05-20 | Special | PDF ↗ |
| K093747 | ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS | C.R. Bard, Inc. | 2010-05-07 | Special | PDF ↗ |
| K100485 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | 2010-03-16 | Special | PDF ↗ |
| K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 | Mpathy Medical Devices, Ltd. | 2009-08-12 | Special | PDF ↗ |
| K083471 | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 | Generic Medical Device, Inc. | 2009-03-03 | Traditional | PDF ↗ |
| K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS | American Medical Systems, Inc. | 2008-09-17 | Traditional | PDF ↗ |
| K072456 | DESARA MESH SLING, MODEL CAL-DS01 | Caldera Medical, Inc. | 2008-05-08 | Special | PDF ↗ |
| K073647 | MINITAPE EXTRA URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2008-03-03 | Special | PDF ↗ |
| K070073 | ALIGN URETHRAL SUPPORT SYSTEM | C.R. Bard, Inc. | 2007-03-21 | Traditional | PDF ↗ |
| K063713 | AMS SMART SLING SYSTEM | American Medical Systems, Inc. | 2007-02-22 | Traditional | PDF ↗ |
| K050516 | T-SLING | Herniamesh S.R.L. | 2006-02-03 | Traditional | PDF ↗ |
| K053296 | MENTOR ARIS SUPRAPUBIC SURGICAL KIT | Mentor Corporation | 2005-12-15 | Traditional | PDF ↗ |
| K052175 | I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 | Uroplasty, Inc. | 2005-10-17 | Traditional | PDF ↗ |
| K051533 | I-STOP | Cl Medical | 2005-08-11 | Traditional | PDF ↗ |
| K051530 | MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. | American Medical Systems, Inc. | 2005-07-08 | Special | PDF ↗ |
| K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT | Mentor Corporation | 2005-03-09 | Traditional | PDF ↗ |
| K042592 | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 | American Medical Systems, Inc. | 2004-12-14 | Traditional | PDF ↗ |
| K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | Mentor Corp. | 2004-11-09 | Special | PDF ↗ |
| K041948 | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS | American Medical Systems, Inc. | 2004-08-11 | Special | PDF ↗ |
| K041176 | URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM | Sofradim Production | 2004-05-17 | Special | PDF ↗ |
| K040787 | MODIFICATION TO SURGICAL MESH POLYMERIC | Boston Scientific | 2004-04-14 | Special | PDF ↗ |
| K040538 | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 | American Medical Systems, Inc. | 2004-03-17 | Special | PDF ↗ |
| K033310 | REMEEX SYSTEM FOR URINARY INCONTINENCE | Specialities Remeex International, S.L. | 2004-01-15 | Traditional | PDF ↗ |
| K033691 | SAFYRE VS AND SAFYRE T | Promedon | 2003-12-19 | Special | PDF ↗ |
| K033568 | GYNECARE TVT OBTURATOR SYSTEM | ETHICON, Inc. | 2003-12-08 | Special | PDF ↗ |
| K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE | Mentor Corp. | 2003-07-17 | Traditional | PDF ↗ |
| K030123 | BIOARC SP SLING KIT | American Medical Systems, Inc. | 2003-02-06 | Special | PDF ↗ |
| K023516 | MONARC SLING SYSTEM | American Medical Systems, Inc. | 2002-11-19 | Special | PDF ↗ |
| K021263 | MODIFICATION TO SPARC SLING SYSTEM | American Medical Systems, Inc. | 2002-05-15 | Special | PDF ↗ |
| K020705 | SIIS#1 TISSUE SUSPENSION SYSTEM | Tag Medical Products | 2002-04-26 | Traditional | PDF ↗ |
| K020110 | MODIFICATION TO TRELEX MESH SURGICAL MESH | Boston Scientific | 2002-04-03 | Abbreviated | PDF ↗ |
| K020663 | MODIFICATION TO SPARC SLING SYSTEM | American Medical Systems, Inc. | 2002-03-28 | Special | PDF ↗ |
| K020007 | SAFYRE SLING SYSTEM | Promedon | 2002-03-21 | Traditional | PDF ↗ |
| K012628 | GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM | Gynecare Center | 2001-10-26 | Traditional | PDF ↗ |
| K013355 | SPARC SLING SYSTEM | American Medical Systems, Inc. | 2001-10-26 | Special | PDF ↗ |
| K012949 | URETEX SUP PUBOURETHRAL SLING | Sofradim Production | 2001-10-04 | Traditional | PDF ↗ |
| K011251 | SPARC SLING SYSTEM | American Medical Systems, Inc. | 2001-08-01 | Traditional | PDF ↗ |
| K982042 | ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 | Island Biosurgical, Inc. | 1998-09-08 | Traditional | PDF ↗ |
| K980482 | TRIANGLE SLING | Influence, Inc. | 1998-03-27 | Traditional | PDF ↗ |
| K974098 | PUBOUURETHRAL SLING | ETHICON, Inc. | 1998-01-28 | Traditional | PDF ↗ |
| K973022 | ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 | Island Biosurgical, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K972651 | IN-SLING | Influence, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K960101 | ISLAND BIOSURGICAL BOLSTER | Island Biosurgical, Inc. | 1996-12-16 | Traditional | PDF ↗ |
Product code OTN · Class II · General, Plastic Surgery. Data: openFDA.