FDA Product Code
FDA Product Code PAH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | Coloplast Corp. | 2024-10-18 | Traditional | PDF ↗ |
| K221874 | Altis Single Incision Sling System | Coloplast A/S | 2023-02-15 | Special | PDF ↗ |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | Caldera Medical, Inc. | 2020-02-07 | Traditional | PDF ↗ |
| K121562 | ALTIS SINGLE INCISION CLING SYSTEM | Coloplast A/S | 2012-11-05 | Traditional | PDF ↗ |
| K123179 | AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING | C.R. Bard, Inc. | 2012-11-02 | Special | PDF ↗ |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | American Medical Systems | 2012-09-07 | Traditional | PDF ↗ |
| K110420 | OPHIRA MINI SLING SYSTEM | Promedon S.A | 2012-05-08 | Traditional | PDF ↗ |
| K103418 | DESARA MINI | Caldera Medical, Inc. | 2011-11-30 | Traditional | PDF ↗ |
| K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 | American Medical Systems, Inc. | 2010-06-07 | Traditional | PDF ↗ |
| K092607 | AJUST ADJUSTABLE SINGLE INCISION SLING | C.R. Bard, Inc. | 2009-11-20 | Traditional | PDF ↗ |
| K091180 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2009-07-14 | Special | PDF ↗ |
| K081275 | BOSTON SCIENTIFIC SURGICAL MESH | Boston Scientific Corp | 2008-08-27 | Abbreviated | PDF ↗ |
| K073646 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2008-02-25 | Special | PDF ↗ |
| K073703 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2008-01-30 | Special | PDF ↗ |
| K071902 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2007-08-24 | Traditional | PDF ↗ |
| K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) | American Medical Systems, Inc. | 2007-03-01 | Special | PDF ↗ |
| K063136 | NEEDLELESS SLING | Specialities Remeex International, S.L. | 2006-12-19 | Traditional | PDF ↗ |
| K052401 | GYNECARE TVT SECUR SYSTEM | ETHICON, Inc. | 2005-11-28 | Traditional | PDF ↗ |
| K023898 | GYNE IDEAS MINITAPE RP DEVICE | Gyne Ideas , Ltd. | 2003-06-18 | Traditional | PDF ↗ |
| K020652 | HERNIAMESH T-SLING | Herniamesh | 2002-05-15 | Traditional | PDF ↗ |
Product code PAH · Class II · General, Plastic Surgery. Data: openFDA.