Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
FDA 510(k) clearance K191416 · decided 2020-02-07
Clearance details
- K-number
- K191416
- Device name
- Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
- Applicant
- Caldera Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-28
- Decision date
- 2020-02-07
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- PAH
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Agoura Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (K242473) | Coloplast Corp. | 2024-10-18 |
| Altis Single Incision Sling System (K221874) | Coloplast A/S | 2023-02-15 |
| ALTIS SINGLE INCISION CLING SYSTEM (K121562) | Coloplast A/S | 2012-11-05 |
| AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING (K123179) | C.R. Bard, Inc. | 2012-11-02 |
| MINIARC PRO SINGLE-INCISION SLING SYSTEM (K121641) | American Medical Systems | 2012-09-07 |
| OPHIRA MINI SLING SYSTEM (K110420) | Promedon S.A | 2012-05-08 |
| DESARA MINI (K103418) | Caldera Medical, Inc. | 2011-11-30 |
| MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (K100807) | American Medical Systems, Inc. | 2010-06-07 |
| AJUST ADJUSTABLE SINGLE INCISION SLING (K092607) | C.R. Bard, Inc. | 2009-11-20 |
| MINITAPE URETHRAL SLING (K091180) | Mpathy Medical Devices, Ltd. | 2009-07-14 |
| BOSTON SCIENTIFIC SURGICAL MESH (K081275) | Boston Scientific Corp | 2008-08-27 |
| MINITAPE URETHRAL SLING (K073646) | Mpathy Medical Devices, Ltd. | 2008-02-25 |
Recalls involving this device
No recalls on record reference this clearance.